HIC.

3: THE ORGANIZATION IMPLEMENTS THE INFECTION PREVENTION

AND CONTROL PROGRAM IN CLINICAL AREAS

SVIMS Hospital implements infection control programme in all areas which includes
emergency room, trauma bay, post-operative ward, Blood bank, dress changing rooms,
visitor’s room, special rooms (Low-Moderate risk areas) apart from high risk areas.
SVIMS Hospital identified various high risk areas* and procedures, and has policies to
prevent infection in these areas.

a. High risk areas of the hospital are identified as

1. Operation Theatres
2. Intensive care units
3. Causality procedure room
4. Obstetrics and Labour room
5. Cardiac catherization Lab
6. Endoscopy Room

7. Emergency Medicine

8. Hemodialysis and renal transplantation units

9. CSSD (Central Sterile Services Department)
10. Laboratories/ sample collection centers
11. Blood bank
12. Dental clinic
13. Food handlers
14. Drinking water

b.The organization adheres to standard precautions at all times*:

Concept of Standard Precautions:
There are a number of precautions designed to protect health care workers from exposure to
blood borne pathogens. While majority of patients infected with HIV/HBsAg/HCV are
asymptomatic at the time of presentation, all patients are considered as having potentially
infectious blood and body fluids. Precautions may vary based on anticipated exposure.
Features of universal precautions:
1. Use of Personal Protective Equipments

1
a) Mask-Protection from air bone infections or situation which lead any splash or sprays of
blood and body fluid
b) Glove –Use glove when we are touching the hand with blood and body fluids, secretions
any wound, or any other contaminated items.
c) Apron-Any Chances of splash or contamination on soiling.
d) Goggles –During positive cases (OT &LR).
e) Boots-If necessary.
f) Caps are worn whenever indicated.
2. Prevention of injury with sharps:
Sharps injuries commonly occur during use of needles and surgical instruments and after use
during disposal.
Precautions to be observed:
1. Needles should not be recapped, bent or broken by hand.
2. Disposable needles & other sharps should be discarded into puncture resistant containers at
the site of procedure.
3. Sharps should not be passed from one HCW (Health Care Worker) to another. The person
using the equipment should discard it. If necessary a tray can be used to transport sharps.
4. All sharps containers to be discarded when 3/4ths full.
c. The organization adheres to hand-hygiene guidelines*:
Hand Washing
Hand washing means vigorous rubbing of hand with soap and water or with any antiseptic
agents.

Types
1. Social hand wash
2. Procedure hand wash
3. Surgical hand wash
Purpose
1. To remove dirt and debris
2. To decontaminate the hands
3. To prevent cross infection
4. To break the chain of infection
Most common mode of transmission of pathogens is via HANDS

2
“Hand washing is the single most important means of preventing the spread of
infection”
When?
 Before and after duty.
 Before each invasive procedures.
 Before and after using gloves.
 After touching of blood or body fluid.
 Before and after touching patients.
 Before touching invasive devices.
 After toileting, urination
Indications for Hand Hygiene
 When hands are visibly dirty, contaminated, or soiled, wash with non-antimicrobial
or antimicrobial soap and water.
 If hands are not visibly soiled, use an alcohol-based hand rub for routinely
decontaminating hands.
WHO’s Five (5) Moments in Hand Hygiene-
Hand hygiene must be practiced –
1. Before touching a patient.
2. Immediately before performing a clean or aseptic procedure, including handling an
invasive device for patient care, regardless of whether or not gloves are used.
3. Promptly after contact with body fluids, excretions, mucous membranes, non-intact
skin, or wound dressings regardless of whether or not gloves were used.
4. After touching a patient and his/her immediate surroundings, even when leaving the
patient’s side.
5. After contact with inanimate objects (including medical equipment and furniture) in
the immediate vicinity of the patient.
Perform hand wash when hands are visibly dirty.

3
 Courtesy: WHO/CDC

Specific Indications for Hand Hygiene

Before:
a) Patient contact
b) Donning gloves when inserting a CVC
c) Inserting urinary catheters, peripheral vascular catheters, or other invasive devices
that don’t require surgery
After:
a) Contact with a patient’s skin
b) Contact with body fluids or excretions, non-intact skin, wound dressings
c) Removing gloves
1. Social hand washing (10 -15 sec)

Indications
i. Before handling food
ii. After visiting toilet
iii. Before and after nursing the patient (Bathing and bed making)
iv. It can be used in community and public places.
2. Procedure hand washing or hygienic hand washing (30sec -1mt)

4
Indications
i. Before each invasive procedures
ii. Before attending immunocompromised patients
iii. Before and between caring for high risk patients
iv. Before and after use of gloves
v. After touching of blood or body fluid
Methods of Hand Washing

1. Wet hands with running water.

2. Obtain soap or detergent that contains antimicrobial agents spread all area of the hands.
3. Vigorous rubbing of hands (all area) about 30 sec to 1 min.
4. Wash hands thoroughly with running water.
5. Rinse and dry.
6. Turn off water with using paper towel or use elbow to close the tap handle

Steps of Procedure Hand Washing

Courtesy: WHO/CDC

5
 i. Palm to Palm
ii. Right palm over left dorsum and left over right dorsum.
iii. Palm to palm finger interlocked.
iv. Back of finger to opposing palms with finger interlocked.
v. Rotational rubbing of right thumb clasped in left palm and vice versa
vi. Rotational rubbing, backwards and forwards with clasped fingers of right hand in left
palm and vice versa.
vii. Rotational rubbing of right wrist and vice versa. Dry thoroughly.

3. Surgical Hand Wash (3-5mts)

i. Prior to all operative procedures
ii. Prior to treatment of all burns cases
iii. Before insertion of all invasive devices (cardiac catheterization, Insertion of all
lines especially arterial and central venous catheterization).
Method
1. Hands are washed up to the elbow freely using disinfectant.
2. Scrubbing of fingers, space between fingers and nails, brush used to scrub the
nails
3. Wash hands thoroughly with running water & after wash the tap should be
closed with elbow
4. Keep the hand finger upright position.
5. Dry the hand with sterile towel.

6
 Courtesy: WHO/CDC
Hand Rub:In Chlorhexidine /alcohol 70% hand rub in all areas

When?

i. Before touching invasive devices

ii. After touching the patient

iii. Before handling the patient

iv. Before preparing any injections

7
d. Organization adheres to transmission-based precautions at all the times.*
Definition of Infection
SVIMS adheres to transmission based precautions at all times. Infection is the invasion and
multiplication of microorganisms. Hospital infection control is important for patients, health
care workers and public.The Infection control Team plays a major role in the prevention and
control of nosocomial infections.
Successful infection prevention and control involves implementing work practices that
prevent the transmission of infectious agents through a two-tiered approach including:

1. Standard precautions: Routinely applying basic infection prevention and control strategies
to minimise risk to both patients and healthcare workers, such as hand hygiene, personal
protective equipment, cleaning and appropriate handling and disposal of sharps

2. Transmission-based precautions (specific precautions): Additional precautions taken based

on the specific transmission of the diseases where standard precautions may not be sufficient
on their own--these specific interventions control infection by interrupting the mode of
transmission.

For better understanding the additional precautions taken with respect to transmission of the
diseases, a knowledge of transmission of infectious agent is necessary (table-1 and table-2).

Table-1: Transmission of infectious agents can occur in a number of ways.

Route Description
1. Contact transmission

8
 Direct transmission i)Transmission through direct skin to skin (hands)
ii)Ingestion , iii) Injection
Indirect transmission Through a contaminated object or person.
2. Droplet transmission Can occur when an infected person
coughs,sneezes or talks and during certain
procedures
Droplets are infectious particles >5µm in size
Droplet distribution is limited by the force of
expulsion and gravity and usually travels short
distance (I meter)
Droplets can also be transmitted indirectly to
mucosal surfaces (e.g. hands)

3. Airborne transmission Small-particle (< 5 µm) aerosols are created

during breathing talking coughing or sneezing and
secondarily by evaporation oflarger droplets in
conditions of low humidity.
aerosols can be dispersed over long distances (>1
meter) by air currents and inhaled by susceptible
individuals.
small particles can transmit infection into small
airways of the respiratory tract

4. Other modes offood. water. Common sources such as contaminated food, water
transmission medications, devices or equipment.

CONTACT PRECAUTIONS

1) What are the risks?

•Direct transmission occurs when infectious agents are transferred from one person to another
person without a contaminated intermediate object or person

o E.g: Through ingestion, injection, or hands

•Indirect transmission involves the transfer of an infectious agent through a contaminated

intermediate object (fomites) or person.

o E.g: Contaminated clothing, patient-care devices, environmental surfaces

•Examples: MDROs, skin infection. bronchiolitis, Burkholderia cepacia. Chicken pox,

Chlamydia, Clostridium difficile.conjunctivitis, CMV. Diphtheria. VRE, Gonorrhoea.
Hepatitis A, E, HSV, leprosy. scabies.

9
2) How should contact precautions be applied?

Key aspects of applying contact precautions include

A, Hand hygiene and PPE.

•Effective hand hygiene is important and the 5 moments for hand hygiene should be
followed at all times

•In C,difficile or non-enveloped viruses (e.g. rotavirus) diarrhoea- Use 4%

chlorhexidine hand wash (Alcohol based rubs not useful).

•Putting on both gloves and gown upon entering the patient-care area helps to contain
infectious agents.

•A surgical mask and protective eyewear must be worn if there is the potential for
generation of splashes or sprays of blood and body substances into the face and eyes

•Remove gown and gloves and perform hand hygiene before leaving the patient-care

B. Patient care equipment for patients on contact precaution

•use patient-dedicated equipment or single-use non-critical patient-care equipment

(e.g. blood pressure cuffs, nebulisers, mobility aids).

•If dedicated equipment is unavoidable, clean the equipment and allow it to dry before
use on another patient,

C. Patient placement

•A single-patient room is recommended

•Keep patient notes outside the room
•Keep patient bedside charts outside the room
•Disinfect hands upon leaving room and after writing in the chart
•Keep doors closed
•If single room is not available
o avoid placing these patients with patients who are at increased risk of an
adverse outcome from infection
o change protective attire and perform hand hygiene between contact with
patients in the same mom

D. Transfer of patients

• Limit transfer of patient as much as possible.

• If transfer within or between facilities is necessary, it is important to
ensure that infected or colonised areas of the patient's body are
contained and covered_

10
 • PPE should be put on before the patient is handled at the destination
DROPLET PRECAUTIONS
1) What are the risks?

• Infectious agents that are transmitted through respiratory droplets (i_e. large-particle
droplets :>51un in size) that are generated by a patient who is coughing, sneezing or talking)
• Transmission via large droplets requires close contact as droplets
generally only travel short distances (<1mcire).
• Examples: respiratory syncytial virus (RSV), MAL7oplavna pneumonia,
parainfluenza, pertussis. plague and meningococcus.
2) How should droplet precautions be applied?
The key aspects of applying droplet precautions include:

A. Hand hygiene and PPE

 Droplet transmission is a form of contact transmission and some infectious agents

transmitted by the droplet route may also be transmitted by contact till is therefore an
important aspect.
 The surgical mask should be put on upon room entry, with practiced before putting
on the mask and after taking off the mask.
 Masks should be put on when the HCW is at a short distance from a patient (1 meter).
 P2 respirator mask is not required.

B. Placement of patients on droplet precautions

 Single-patient room is ideal

 When single-patient rooms are in short supply
 Priority is given to patients who have excessive cough and sputum production for
single-patient room placement
 Place together in the same room (cohort) patients who are infected with the same
pathogen and are suitable roommates

• If it becomes necessary to place patients who require droplet precautions in a room with a
patient who does not have the same infection.

o Ensure that patients are physically separated (> i metre apart) from each other and
draw the privacy curtain between beds to minimise opportunities for close contact
o Avoid placing patients on droplet precautions in the same room with patients who have
conditions that may increase the risk of adverse outcomes (e.g. immunocompromised
patient , cystic fibrosis, cardiac conditions or muscular dystrophy)

C. Transfer patients on droplet precautions

 Ask the patient to wear a mask while they are being transferred and to follow
respiratory hygiene and cough etiquette

11
 Steps in respiratory hygiene and cough etiquette

Anyone with signs and symptoms of a respiratory infection. regardless of the cause. should
follow or be instructed to follow respiratory hygiene and cough etiquette as follows:

 Cover the nose/mouth with disposable single-use tissues when coughing. sneezing.
wiping and blowing noses
 Dispose of tissues in the nearest waste receptacle or bin after use.
 If no tissues are available, cough or sneeze into the inner elbow rather than the hand.
 Practice hand hygiene after contact with respiratory secretions and contaminated
objects materials.
 Keep contaminated hands away from the mucous membranes of the eyes and nose.

In high risk OPDs such as pulmonary medicine OPD

 Give mask to patients with cough and make separate queue away from the general
queue.
 Sign board indicating how to follow
 Enough mask, tissue paper, hand rub and BMW bins
 Sputum collection should be done in open space or in a well ventilated room

AIRBORNE PRECAUTIONS

1. Why are airborne precautions important?

 Airborne precautions prevent transmission of microorganisms that remain infectious
over time and distance when suspended in the air
 Agents include measles (rubeola). chickenpox (Varicella) and M.tuberculosis
2. How should airborne precautions he applied?
The key aspects of applying, airborne precautions relate to:

A. Personal protective equipment

 Wear a correctly fitted P2 respirator (e.g. N95 mask) when entering the patient-
care area.
 Gloves and gown may be used as per standard precaution
B. Patient placement
 Single room is advisable, preferably negative pressure morn
 Ask patients la wear a surgical mask if he is with other patients in a room
 Door to the room should remain closed_
 Only staff fir visitors who are immune to the specific infectious agent should enter
the room. if possible,
C. Transfer of patients
 Limit transfer as much as possible,
 Patient should wear a correctly fitted surgical mask.
 Should follow respiratory hygiene and cough etiquette
 Any associated skin lesions with the condition should be covered.

Table: Application of standard and transmission based precautions.

12
Type Example Single Gloves Gown Mask Eye Handling Visitors
room or protection of
cohort equipment

Standard Should be Not As If soiling Wear As Reprocess No

followed: all required required likely surgical required before addition
patients mask during reuse on al
procedures next precauti
All blood/fluid likely to patient ons.
generate
All sharps
splash from
Irrespective of blood and
their infection body fluids.
status

Contact MDROs Essential Essential Essential Surgical As Single use Same

mask- required or precauti
C.difficile required if reprocess ons as
infectious before staff.
Diarrheal
agent is also reuse on
pathogens
transmitted next
Highly by droplet. patient.
contagious skin
infections.

Droplet RSV Essential As If soiling Surgical As Same as Restrict

required likely mask is required contact visitor
Mycoplasma essential numbers
and
Parainfluenza
precauti
Pertussis ons
same as
Plague and for staff.
Meningococcus

Airborne Pulmonary TB, Essential As If soiling N95 As Same as Restrict

Chicken pox, (negative required likely respirator required contact visitor
Measles, pressure) essential. numbers
SARS. and
precauti
ons
same as
for staff.

*Gloves are used when likely to touch blood, body fluids and contaminated items

**Eye protection is required during procedures likely to generate contamination with

aerosols.

13
Table: type of precautions for specific infections and conditions.

Disease Agents Precautions Comments

required
(Over and above
standard
precautions)
1) Diarrhoea
Enteric pathogens Vibrio,E.coli,salmonella, Standard and C.difficile and Rota
Campylobacter, shigella, contact precautions virus needs contact
C.difficile, rota virus, norovirus (pediatrics and precautions, others
and others. adult) need standard
precautions.
2) Meningitis
Neisseria meningitides Droplet precautions
H.influenzae for first 24 hrs of
antimicrobial
therapy mask and
face protection is
needed for
intubation.
Enterovirus Contact precaution
for infants and
children
M.tuberculosis Airborne
precautions needed
for pulmonary
infiltrate, airborne
precautions plus
contact precautions
if potentially
infectious draining
body fluid present.
3) Rash or exanthems generalized
Petechial/ Neisseria meningitidis Droplet precautions
ecchymotic with for first 24 hrs of
fever antimicrobial
therapy
If a travel history Ebola, Lassa. Marburg viruses Droplet precaution During likely blood
toa area with viral plus contact exposure emphasize
hemorrhagic fever precautions, sharps safety and
outbreak is there face/eye protection barrier precautions
Vesicular rash Varicella –zoster, herpes Airborne plus Contact precautions
simplex ,Variola,Vaccinia contact precautions only, if herpes
simplex, localized
zoster in an
immunocompromise
d host or vaccinia
virus most likely
Maculopapular Measles,parvo virus,rubella Airborne If measles ruled out,

14
with cough, coryza precautions only droplet
and fever Droplet precautions precautions
4) Respiratory infections
Sore throat S. pyogenes Droplet precautions
C.diphtheriae
Common cold Rhinovirus Droplet precautions
Cough/fever/ M.tuberculosis Airborne If tuberculosis is
pulmonary Respiratory viruses precautions plus unlikely or there are
infiltrates S.pneumoniae,S.aureus,H.influenz contact precautions negative pressure
a,Mycoplasma,Pertussis,Pneumon rooms or respirators
ic plague unavailable ,use
droplet prewcautions
instead of airborne
precautions
Cough/fever/ M. tuberculosis Airborne plus If SARS and
pulmonary Severe SARS – Co V contact precautions tuberculosis unlikely
infiltrate history of Avian influenza plus eye protection use droplet
recent travel ( 10- precautions instead
21 days) to of airborne
countries with precautions
active out breaks of
SARS, avian
influenza
Respiratory RSV Contact plus Droplet precautions
infection Para influenza virus droplet precautions may be discontinued
particularly Adenovirus when adenovirus and
bronchiolitis and Influenza influenza have been
pneumonia Human metapneumo virus ruled out
5) Skin or wound infection
Abscess or draining Staphylococcus aureus. contact precautions Add droplet
wound that cannot Group A streptococcus precautions for first
be covered 24 hrs of appropriate
antimicrobial
therapy if invasive
group A
streptococcal disease
is suspected
Impetigo S. aureus contact precautions
Furunculosis S. aureus Infant/children –
contact
Scalded skin S. aureus contact precautions
syndrome
Pressure ulcer contact precautions
infected
6) Sexually transmitted diseases
Genital erosions, N.gonorrhoeae, Standard
ulcerations ,dischar Syphilis,Trichomoniasis precautions
ge
7) Blood borne infections

15
Fever, myalgia or Hepatitis B,C,D Standard Immunize and test
jaundice or any HIV precautions all HCWs for
other signs Dengue fever hepatitis
suggestive of blood B,Occupational
borne diseases exposure protocol
for blood borne
viruses , post
exposure
prophylaxis if
indicated
8) Conjunctivitis
Conjunctival Chlamydia trachomatis, Acute Standard
congestion bacterial, Gonococcal, Acute viral
precautions
discharge and other hemorrhagic conjunctivitis Contact precautions
signs for acute viral
hemorrhagic
conjunctivitis
9) MDROs (multi drug resistant organisms)
Isolated MDROs Infection or colonization contact precautions contact precautions
from clinical (e.g.MRSA,VRE,VISA/VRSA,ES recommended in
specimens BLs, Resistant S.pneumoniae settings with
evidence of ongoing
transmission or
wounds that cannot
be contained by
dressings
10) Fungal diseases
Tinea, Aspergillosis,Candida Standard
precautions
11) Miscellaneous
Leprosy Standard
precautions
Leptospirosis Standard Person to person
precautions transmission is rare
Pertussis Droplet precautions
Rabies Standard
precautions
Person to person
transmission is rare
if patient bites
another person
wash exposed area
thoroughly and
administer post
exposure
prophylaxis
Rickettsial fever Standard
precautions
Tetanus Standard

16
 precautions
Typhoid Standard
precautions
Congenital rubella Contact precaution
Pediculosis Head lice contact,
others – standard
Scabies Contact
Polio contact precautions
Extra pulmonary TB with Airborne and
draining lesion contact
References:

1 Update of the Australian Guidelines for the prevention and Control of Infection in
Health care (2010 Guidelines)
https://www.nhmrc.gov.au/guidelines-publications/cd33

2. Damani NPittet D. Manual of Infection Commit Procedures. 3rd ed. London:

Oxford university press, 2012.

3.Siegel JD, Rhinchart E. Jackson M, Chiarello L. 2007 Guideline for isolation

precautions: preventing transmission of infectious agents in health care settings. Am J
Infect Control. 2007;35: S65-S164.

Clostridium difficile infection:

Introduction

Clostridium difficile is an anaerobic, Gram-positive bacterium associated with

pseudomembranous enterocolitis(PMC).

C.difficile has now become the most frequent cause of hospital-acquired diarrhoea
especially in west because of emergence of the 027 hypervirulent epidemic strain.

RISK FACTORS

1. Exposure to especially high-risk antibiotics(3rd-generation cephalosporins,

Clindamycin and quinolones)
2. Suppression of normal flora ( conversion of primary bile salts to secondary
bile salts is inhibited, secondary bile salts usually resists the germination of
spores)
3. Advanced age (>65 years)
4. Immunosuppression (malignancy, defects in phagocytic and humoral host
defence)
5. Prolonged hospital stay
6. Gastric acid suppressant medications
7. Use of electronic rectal thermometer
8. Inflammatory bowel disease
9. Exposure to hyper virulent 027 strain of C. difficile.

17
 10. Gastrointestinal and transplant surgery
11. Enteral (post-pyloric) tube-feeding(rich in amino acids good medium for
C.difficile growth)

PATHOGENESIS

C difficile spores spread via the faecal oral route - The spores resist the acidity of the
stomach → germinate into the vegetative form in the small intestine →vegetative
forms colonize on the mucosa through surface proteins (adhesins) →C. Difficile
toxins (A and B) came damage to enterocytes →results in cytoskeletal changes and
the release of fluids and inflammatory products leading to colitis, pseudomembranous
colitis(PMC), and profuse watery diarrhoea.

Hypervirulent epidemic (BI/NAPI/027) toxin type III) strain produce 20-fold higher
concentrations of toxin A and toxin B leading to community acquired CDI in some
population with associated risk factors such as increased PM usage.

CLINICAL FEATURES

• CM can run the gamut from asymptomatic colonization to severe

PMC, toxic megacolon, and death.

• Mild disease: characterized by diarrhea in the absence of colitis

• Moderate disease: diarrhea with evidence of colitis

• Severe disease: Colitis with elevated temperature reaching 40°C,

PMC and hypoalbuminemia

• Fulminant disease: severe abdominal pain, profuse diarrhea, or sometimes no

diarrhea, toxic. megacolon.

Laboratory diagnosis:

Type of Test Sensitivity Specificity Comment

Stool culture for C. difficik ++++ +++ Most sensitive test
CCFA (Cycloserine Cefoxitin Less specific if not
Fructose Agar) yellow colonies toxigenic Turnaround time
too slow
Cell culture cytotoxin +++ ++++ Highly specific but not as
neutralization may sensitive as stool culture
Slow turnaround time
Toxin A or toxins A and B ++ to +++ +++ Rapid results, less TAT
instool but not as sensitive as
(EIA, ICT or latex stool culture or cell
agglutination) culturecytotoxin lest

18
 +++ to ++++ +++ Rapid result ,less TAT
C difficile common GDH found in both
antigen instool toxigenic and non
(glutamate toxigenic strains
dehydrogenase) (FAA, More sensitive and less
ICT or latex specific than EIA for
agglutination) toxins

GDH and toxin in stool +++ to ++++ ++++ Rapid result ,less TAT
(EIA ,ICT or Latex sensitivity same as GDH ,
agglutination ) specificity increases
PCR for C.difficile toxin B ++++ ++++ Detects toxigenic
gene in stool C.difficile
Less TAT
More sensitive than EIA
for toxin testing and at
least a specific
Colonoscopy or + ++++ Highly specific if
sigmoidoscopy pseudomembranes are
seen
Sensitivity – very low
Note: ++++,> 90%;+++,71 – 90%;++,51-70%; +,50%

PREVENTION STRATEGIES

19
Implementation of C difficile care bundle

I. Stop antibiotic if possible or change to low-risk narrow-spectrum agents.

2.Early diagnosis to identify cases and start treatment to control symptoms

3.Prompt isolation of patients as soon as possible in a single mom with en suite toilet

4, Implement infection control precautions

5. Clean and disinfect environment

6. Decontaminate/sterilize patient care items/equipment

Infection control measures

1. Strict hand washing with soap and water before and after contact with patients and
environmental surfaces is the most effective

2. Use chlorhexidine 4% hand wash as alcohol hand disinfectants are not effective against C.
difficile spores.

3. Transfer of patients between wards/units should be restricted unless considered essential.

4. Use of non-sterile single-use gloves and a plastic apron for patient care and hands arc
washed after removing gloves.

5. Environment and other soiled areas must be thoroughly and frequently cleaned and then
disinfected using a I% of freshly prepared hypochlorite solution.

6. Separate cleaning equipment must be reserved for cleaning the environment

7. Patients may remain colonized for long time. So if patient is transferred, then the
subsequent hospital must be informed.

Management

•Discontinuation of the precipitating antibiotics

•Avoid antiperistalatic medication like opiates which results in retention of toxin

•Rehydration of patient

•Oral Metronidazole (500 mg p.o tid for 10 day) - mild to moderate disease

•Oral vancomycin ( 125 mg p.o qid for 10 days) - serious CDI

•Combination therapy with enteral vancomycin & Intravenous metronidazole in cases of ileus
or toxic megacolon,

•Fidaxomicin- it is a macrolide antibiotic(200 mg p.o bid for 10 days). It can be used in

highest risk for relapse.

20
•Intravenous immunoglobulin( 150-400 mg/kg) passively provide antibodies to neutralize the
C. difficile toxins, primarily toxin A

•Fecal transplant- it involves replenishing of the gut flora with donated feces from a screened
healthy donor.

Why CDI is less common and severe in India:

Though not fully understood, possible contributory factors are

•predominantly vegetarian diet among Indians

•Over the counter supply and frequent use of metronidazole

•Non adherence to complete course of antibiotics

•A robust anamnestic antibody response due to repeated infections and

•Perhaps the virulent, more toxigenic strains may not be common in our country.

However, CDI’s in India have always been found when looked for. It is much more likely
that more cases will come to light as the toxin assays and more sophisticated methods of
diagnosis are used on a larger scale.

CDI LAB-ID EVENT SURVEILLANCE FOR C.DIFFC1LE

C. difficile testing in the laboratory is performed routinely only on unformed (i.e. conforming
to the shape of the container) stool samples.

•C. difficile Lab identification (LablD) events may be monitored from all available inpatient
locations as well as all available affiliated outpatient locations

•Surveillance will NOT be performed in NICU, SCN, babies in LDRP. Well-baby nurseries
or well-baby clinics.

CDI-positive laboratory assay: Any laboratory test positive for C.difficiletoxin

A and B (PCR, EIA, 1CT, Culture) performed
on unformed stool
Duplicate C. difficile-positive test: Any positive laboratory test for C.difficiletoxin
A andfor B from the same patient and location,
following a previous C.difficile toxin-positive
laboratory result within the past two weeks [14
days]
Recurrent CDI LabID Event: Any CDI LabID Event from a specimen obtained >
14 days (2 weeks) and ≤ 56 days (8 weeks) after
the most recent CDI LablD Event for that patient.

21
 Incident CDI LablD Event: Any CDI LabID Event from a specimen obtained
> 56 days (8 weeks) after the most recent CDI
LabID Event (or with no previous CDI LablD
Event documented) for that patient.
Community-Onset CDI (CO): LabID Event collected in an outpatient location or
an inpatient location <3 days after admission to
the facility.
Community-Onset Healthcare Facility- CO LablD Event collected from a patient who was
Associated discharged from the facility ≤4 weeks prior to
current date of stool specimen collection.
Data from outpatient locations (e.g._, outpatient
encounters) are not included in this definition.
Healthcare Facility-Onset: LablD Event collected >3 days after admission
to the facility
(i.e., on or after day 4).

*The date of specimen collection is considered Day 1.

References:

1. National Healthcare Safety Network (NHSN) (Internet).Centers for Disease Control and

Prevention; [cited November 21, 2016]. Available from: https://www.cdc.gov/nhsn/

2. Damani NPittet D. Manual of Infection Control Procedures. 3rd ed. london: Oxford
university press; 2012.

3. Harrison’s Internal Medicine, 19th Edition.

e.Organization adheres to Safe Injection and Infusion Practices*

Safe Injection and Infusion Practices

A safe injection, lancet procedure or intravenous device insertion is one that:

A. Does not harm the recipient.

B. Does not expose the provider to any avoidable risk.

C. Does not result in any waste that is dangerous for other people.

Purpose:

The purpose of SAFE Injection and Infusion Practices is to promote implementation of safe
practices associated with thefollowingmedical procedures:

 Intradermal, subcutaneous and intramuscular needle injections

 Intravenous infusions and injections

22
  Lancet procedures.

General safety practices

This section describes the following practices that are recommended to ensure the safety
of injections and related practices:

 Hand hygiene

 Gloves where appropriate

 Other single-use personal protective equipment

 Skin preparation and disinfection

A. Hand hygiene- Perform hand hygiene BEFORE:

 Starting an injection session (i.e. preparing injection and giving injections)

 Coming into direct contact with patients for health-care related procedures

 Putting on gloves (first make sure hands are dry).

A. Hand hygiene- Perform hand hygiene AFTER:

 An injection session

 Any direct contact with patients

 Removing gloves.

Skin Preparation And Disinfection

To disinfect the skin, use the following steps

1. Apply a 60–70% alcohol-based solution (isopropyl alcohol or ethanol) on a single-use

swab or cottonwool ball. DO NOT use methanol or methyl-alcohol as these are not safe
for human use.

2. Wipe the area from the centre of the injection site working outwards, without going over
the same area.

3. Apply the solution for 30 seconds then allow it to dry completely.

23
 Injection Devices :The management of SVIMS shall ensure that an adequate supply of
single-use devices is available, to allow providers to use a new device for each procedure.

G. Practical Guidance On Use Of Injection Devices

When using a sterile single-use device

a) Use a new device for each procedure, including for the reconstitution of a unit of
medication or vaccine;

b) Inspect the packaging of the device to ensure that the protective barrier has not been
reached;

c) Discard the device if the package has been punctured, torn or damaged by exposure to
moisture, or if the expiry date has passed.

H. Medication

I. When giving medication:

a) NOT use a single loaded syringe to administer medication to several patients (i.e.ensure
one needle, one syringe, one patient!)

b) DO NOT change the needle in order to reuse the syringe

c) DO NOT use the same mixing syringe to reconstitute several vials

d) DO NOT combine leftover medications for later use.

Single-dose vials – Whenever possible, use a single-dose vial for each patient, to reduce
cross contamination between patients.

Multi dose vials – Only use multi dose vials if there is no alternative.

i. Open only one vial of a particular medication at a time in each patient-care area.

ii. If possible, keep one multi dose vial for each patient, and store it with the
patient’s nameonthe vial in a separate treatment or medication room.

iii. DO NOT store multi dose vials in the open ward, where they could be
contaminated with spray or spatter.

Discard a multi dose vial:

i. If sterility of content is compromised

24
 ii. If the expiry date or time has passed (even if the vial contains antimicrobial
preservatives)

iii. If it has not been properly stored after opening

iv. Within 24 hours of opening, or after the time recommended by the manufacturer,
if the vial does not contain antimicrobial preservatives
v. If found to be undated, improperly stored, inadvertently contaminated or
perceived to be contaminated, regardless of expiry date.
Preparing injections

Injections should be prepared in a designated clean area where contamination by blood

and body fluids is unlikely.

Practical guidance on preparing injections

Three steps must be followed when preparing injections.

 Keep the injection preparation area free of clutter so all surfaces can be easily
cleaned.

 Before starting the injection session, and whenever there is contamination with blood
or body fluids,clean the preparation surfaces with 70% alcohol (isopropyl alcohol or
ethanol) and allow drying.

 Assemble all equipment needed for the injection

 Sterile single-use needles and syringes,

 Reconstitution solution such as sterile water or specific diluents,

 Alcohol swab or cotton wool,

 Sharps container.

Labelling

After reconstitution of a multi dose vial, label the final medication container with

 Date and time of preparation

 Final concentration

25
  Expiry date and time after reconstitution

 Name and signature of the person reconstituting the drug.

For multi dose medications that DO NOT requires reconstitution, add a label with:

 Date and time of first piercing the vial

 Name and signature of the person first piercing the vial.

Administering Injections

Anaseptic technique should be followed for all injections.

Practical guidance on administering injections

General

When administering an injection:

 Check the drug chart or prescription for the medication and the corresponding
patient’s name and dosage

 Perform hand hygiene

 Wipe the top of the vial with 60–70% alcohol using a swab or cotton-wool ball

 Open the package in front of the patient to reassure them that the syringe and needle
have not been used previously

 Using a sterile syringe and needle, withdraw the medication from the ampoule or vial.

Reconstitution

 If reconstitution using a sterile syringe and needle is necessary, withdraw the

reconstitution solution from the ampoule or vial, insert the needle into the rubber
septum in the single or multi dose vial and inject the necessary amount of
reconstitution fluid.

 Mix the contents of the vial thoroughly until all visible particles have dissolved.

 After reconstituting the contents of a multi dose vial, remove the needle and syringe
and discard them immediately as a single unit into a sharps container.

26
Delay in administration

 If the dose cannot be administered immediately for any reason, cover the needle with
the cap using a onehand scoop technique.

 Store the device safely in a dry kidney dish or similar container.

Important points

 DO NOT allow the needle to touch any contaminated surface.

 DO NOT reuse a syringe, even if the needle is changed.
 DO NOT touch the diaphragm after disinfection with the 60–70% alcohol till it dries
up (isopropyl alcohol or ethanol).
 DO NOT enter several multi dose vials with the same needle and syringe.
 DO NOT re-enter a vial with a needle or syringe used on a patient if that vial will be
used to Withdraw medication again (whether it is for the same patient or for another
patient)

Prevention of sharps injuries to health workers

Use of best practices can help to prevent sharps injuries to health workers
Practical guidance on prevention of sharps injuries
To avoid sharps injuries:
1. Ensure that the patient is adequately prepared for the procedure
2. Do not bend, break, manipulate or manually remove needles before disposal
3. Avoid recapping needles, but if a needle must be recapped, use a single-handed scoop
technique
4. Discard used sharps and glass ampoules immediately after use in the location where they
were used, disposing them into a robust sharps container that is leak and puncture resistant
5. Place the sharps container within arm’s reach (preferably in a secured area) to allow for
easy disposalof sharps
6. Seal and replace sharps container when the container is three quarters full.

27
B. Staff at SVIMS, who are in direct contact with patients, shall wear non-sterile, well-
fitting latex or latex-free gloves when coming into contact with blood or blood product.
Indications for glove use in injection practice are

Key Elements Indications Precautions

Glove use Wear non-sterile, well-fitting, single-use When undertaking injections,
gloves: DO NOT use gloves:
•when there is a likelihood of coming into •for routine Intradermal,
direct contact with a patient’s blood or other subcutaneous and
potentially infectious materials (e.g. body intramuscular injections
fluids, moist body substances and saliva [in •if the health worker’s skin
dental procedures]), mucous membranes is intact
and nonintact skin •when performing •if the patient’s skin is intact.
venipuncture or venous access injections, Gloves DO NOT provide
because of the potential for blood exposure Protection against needle-
at the puncture site stick or other puncture
•if the health worker’s skin is NOT intact wounds caused by sharp
(e.g. through eczema, or cracked or dry objects.
skin) Needles, scalpels and other
sharps should be handled
with extreme caution.

Other Single-Use Personal Protective Equipment

 Masks, eye protection and other protective clothing ARE NOT indicated for the
injection procedures unless exposure to blood splashes is expected.

 When using single-use personal protective equipment, dispose of the equipment

immediately after use.

28
g. An appropriate antibiotic policy is established and documented*

Document Name: Antibiotic Policy

Date Created : 05/06/2014

Date Revised : 15/06/2017

Dr Alladi. Mohan, HOD & Professor of Medicine

Dr K.K. Sharma, HOD & Professor of Microbiology

Created by :
Dr N. Ramakrishna, Assistant Professor of Microbiology

Dr R. Jayaprada, Assistant Professor of Microbiology

Dr K.K.Sharma- Member Secretary

Verified by:
Dr A. Mohan- Member of HICC

Medical Superintendent
Approved By : Name :Dr Alok Sachan

Signature :

Pharmacologist
Reviewed By : Name : Dr. Vijayachandra Reddy

Signature :

Director
Issued By : Name : Dr. T.S. Ravi Kumar

Signature :

Chief Pharmacist
Responsibility of
Updating : Name : Subramanyam

Signature :

29
A. Sl.Order Particulars

A Purpose

B Scope

C Guideline for Antibiotic Treatment and Prophylaxis

Purpose:

 Improve patient care by promoting the best practice in antibiotic prophylaxis and therapy.
 Make better use of resources by using cheaper drugs where possible.
 Retard the emergence and spread of multiple antibiotic – resistant bacteria.
 Improve education of doctors by providing guidelines for appropriate therapy.
 Eliminate the use of unnecessary or ineffective antibiotics and restrict the use of
expensive or reserve drugs.

B. Scope: Hospital Wide

 Consider whether or not the patient actually requires an antibiotic.

 Avoid treating colonized patients who are not actually infected.
 In general do not change antibiotic therapy if the clinical condition is improving.
 If there is no clinical response within 72 hours, the clinical diagnosis, the choice of
antibiotic and/or the possibility of a secondary infection should be reconsidered.
 Give the antibiotic for the minimum length of time that is effective.
 Review the duration of antibiotic therapy after 5 days.
 For surgical prophylaxis start the antibiotic one day before induction of anesthesia and
continue for a maximum of five days.
 Use catheters only when essential; remove when no longer essential.
 Target the pathogen – obtain cultures from the patient; target empiric therapy to likely
pathogens; target definitive therapy to known pathogens.
 Isolate the pathogen – use standard infection control and isolation precautions
 Break the chain of contagion – KEEP YOUR HANDS CLEAN
ANTIMICROBIAL POLICY AND ANTIMICROBIAL STEWARDSHIP

Introduction

The annual antibiogram should be prepared by microbiology department in coordination with

medical and surgical departments. Antibiotic susceptibility profile analyzed regularly and the

30
common resistance patterns of the bacterial isolates to be reported and discussed in the HICC
meetings and the antibiotic policy to be reviewed accordingly.

Antibiotic policy need to be prepared in consultation with respective clinical departments.

Antibiotic policy shall be prepared using following general principles:

1. Data is analyzed on a quarterly basis as per hospital records.

(a) Common etiological agents as per

(i) Site of infection

(ii) Age groups

(iii) Patient location – outdoor (OPD), indoor (wards & critical care areas)

(b) Antibiogram data as per

(i) Site of infection

(ii) Age groups

(iii) Patient location – outdoor (OPD), indoor (wards & critical care areas)

(c) Unusually resistant organisms to be confirmed and submitted for further characterization
to National Centre for Disease Control (NCDC).

2. Standard treatment guidelines [categorization of patients as per age and Community

acquired infections (CAI) / Health care associated infections (HCAI)]

(a) Guidelines for empirical antimicrobial therapy as per common clinical syndromes

(i) Adults & older children

1. Blood Stream Infections (BSI)

2. Meningitis

3. UTI

4. Pneumonia (a) Community Acquired Pneumonia (CAP) (b) Ventilator Associated

Pneumonia (VAP)

31
5. GIT Infections

6. Conjunctivitis

7. Otitis Media

8. Tonsillitis / Pharyngitis

9. Skin and Soft Tissue Infection (SSTI)

10. Genital Infections

11. Osteomyelitis

(ii) Neonates (special conditions) 1. Sepsis 2. Meningitis

(iii) Infants & Small Children (special conditions) 1. Meningitis 2.Sepsis 3. Pneumonia

(b) Classification of Antimicrobials into Access, Watch and Reserve drugs as per
WHO,2017.

(c) Chemoprophylaxis (i) Pre-operative antimicrobials (ii) Other invasive procedures (iii)
Special high risk groups e.g. Prophylaxis for rheumatic fever, splenectomy patients, and
Immuno-compromised patients

(d) Special clinical syndromes (e.g. STIs)

3. Prescription auditing

4. Review of surveillance data generated from antibiogram & prescription auditing.

5. Education and training for all infection control activities in collaboration with the
Hospital Infection Control Committee.

Measures to control spread of antibiotic resistance:

I .Appropriate antimicrobial use:

1. Each health care facility should have an antimicrobial use programme. The goal is to
ensure effective economical prescribing to minimize the selection of resistant
microorganisms.

2. Formulation of guidelines with a multidisciplinary approach using the local antibiogram.

32
3. Provide ongoing education on rational use of antibiotics to clinicians and ensure
implementation of antibiotic policies.

4. Restricted antibiotic use.

5. Use must be justifiable based on clinical diagnosis.

6. Before initiating antibiotic treatment, appropriate specimens for bacteriological

examination must be submitted to laboratory and selection of an antibiotic must be based on
the sensitivity pattern, patient tolerance, and cost.

7. An agent with as narrow a spectrum as possible should be used with appropriate dosage
and duration of antimicrobial therapy.

8. The correct dose must be used.

9. Control antibiotic use - Selected antibiotics may be restricted in use. Cyclic rotation of
antibiotics in a class - Discontinuation of antimicrobial therapy based on predefined criteria.

10. Carry out periodic prescription audits.

11. Restriction of hospital formulary through pharmacy.

12. Standard and contact Precautions including rigorous adherence to hand hygiene,
appropriate use of PPE.

13. Isolation and cohorting of patients infected or colonized with Multi-drug resistant
organisms (MDROs).

14. Education and training of Health Care Pharmacist (HCP).

15. Increased environmental cleaning and patient-dedicated equipment.

16. Proper sterilization and disinfection.

17. Surveillance for Multidrug resistant organisms (MDRO’s) especially in high risk areas.

Screening of patients and staff for multi drug resistant organisms (MDROs)

INTRODUCTION

MDRO can be defined as a bacterial isolate which is resistant to one or more agents in three
or more different classes of antimicrobials that the isolate is expected to be susceptible to.

33
 Endemic MDROs Emerging MDROs

 Methicillin-resistant Staphylococcus aureus  Carbapenem resistant

(MRSA) Enterobacteriaceae (CRE)
 Vancomycin-resistant Staphylococcus
 Multi-resistant Pseudornonas species mimics (VRSA)
 Multi-resistant Acinelobacter species
 Vancomycin-resistant Enterococcus (VRE)

Importance of MDROs in Hospitals:

The morbidity and mortality rates associated with MORO infections are high and the spread
of MDROs in hospitals will increase the burden on healthcare infrastructure contributing to
increased costs of care due to prolonged hospital stays and the need for more expensive
drugs. Stringent infection control strategies should be developed to prevent and control the
spread of MDROs and to minimize the risk of cross infection to other patients, staff and
visitors.

Factors aiding in the transmission and persistence of MDROs in hospitals:

• Presence of vulnerable patients (with compromised immunity and indwelling devices)

• The reservoir of infected or colonized patients

• The selective pressure exerted by antimicrobial use

• The effectiveness of local infection prevention and control measures

PREVENTION AND CONTROL STRATEGIES FOR MDROs

A two level approach has been recommended for the prevention and control for MDROs:

1. Core strategies Applicable in any situation where MDRO infection or colonization is

suspected or identified

2. Organism-based or resistance mechanism -based approaches: Applicable if incidence or

prevalence of MDROs are not decreasing despite implementation of the core strategies Core
strategies

The implementation of transmission-based precautions for all patients colonized or infected

with MDR0s, which include!

• Performing hand hygiene and putting on gloves and gowns before entering the patient-care
area

34
• Using patient-dedicated or single-use non-critical patient-care equipment

• Using a single-patient room or cohorting patients with the same strain of MDRO in
designated patient-care areas

• Ensuring consistent cleaning and disinfection of surfaces in close proximity to the patient.

Organism-specific approach

Recommended when the incidence or prevalence of MDROs is not decreasing despite

implementation of the core strategies and this approach focuses on:

• The type of MDRO (e.g. prioritization of available isolation facilities)

• The healthcare area (e.g. intensive care or other units with higher risks of transmission)

• Patient factors (e.g, whether the consequences of infection are severe)

• Available resources (e.g. feasibility of screening)

• Whether interventions to interrupt transmission are available (e.g. decolonization for

MRSA)

Further Measures

I.Targeted screening-Timely active screening to identify colonized patients combined with

the use of contact precautions. Screening involves collecting specimens Iron] the patient with
subsequent laboratory analysis of samples. In a risk assessment approach to screening,
considerations include the endemicity, the prevalence of infection, and the likelihood of
MDRO carriage. Clinicians and the infection control professionals should be informed of
both negative and positive screening results promptly.

2.Decolonization- Interventions may be topical, systemic or combinations of systemic and

topical therapy. Topical include use of chlorhexidine whole body washes and topically
applied antimicrobial agents like mupirocin. Systemic includes orally administered antibiotics
(tetracyclines, fusidic acid, ciprofloxacin, rifampin and trimethoprim-sulfamethoxazole)

3.Surveillance and timely feedback- Increased surveillance is important to monitor the

effect of interventions designed to control particular MDR s. Surveillance information should
be fed hack to health care workers and facility management promptly

Antibiotic Stewardship is a key strategy to decrease the incidence of MDROs in hospitals

MDRO clearance criteria for patients

1. More than 3 months elapsed time from the last positive specimen

2. All wounds healed, no indwelling medical devices present

35
3. No exposure to any antibiotic or antiseptic body wash for at least 2 weeks prior to
screening

4. In the case of MRSA, no exposure to specific anti-MRSA antibiotic therapy in the past
three months

5. Consecutive negative screens from screening sites on two separate occasions OR

evaluation of a single set of screening swabs with a broth amplification technique

Some patients with VRE may appear to be 'clear' with time but relapses with antibiotic
therapy. Admission and interval screening in specialized units is an important way to detect
new or relapsed VRE or MDR-GNB colonization.

METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA)

Active surveillance cultures help to identify colonized MRSA patients in a facility or in a

specific unit and to evaluate the success of an intervention that was implemented in response
to increased MRSA infections or a MRSA outbreak

Suggested approach to screening for MRSA

Whom to screen:

I .Patients at high risk of carriage (Group I ): Known to be previously infected or colonized

with MRSA, frequent re-admissions to hospital, those from known MRSA prevalent
community

2. Healthcare workers (Group 2) epidemiologically linked to single-strain outbreak in

hospital

3. Patients in high-risk units (Group 3): ICU/high dependency unit. burns & pre-operative
unit

When to screen:
I. Group 1 and Group 3 - At the time of admission
2. Group 2- After confirmation of epidemiological evidence and 2 weeks after decolonization

Samples:
Swabs from nose, perineum /groin, operative and wound sites, abnormal or damaged skin.

36
 Laboratory identification:
1. Direct culture methods: Mannitol salt agar with 6 µg/ml of Oxacillin/
Chromogenic media
2. Broth enrichrnent culture
3. PCR to detect Alec -A gene

Management:

Apply stringent hand hygiene, contact precautions and core strategies including isolating
and cohorting patients. increased environmental cleaning and dedicated patient equipment
Tagging of MRSA positive patients for easy identification on readmission

Decolonization therapy for MRSA

Recommended for

• Healthcare workers epidemiologically linked to transmission

• Patients having prolonged hospitalization

• Patients with chronic conditions likely to be readmitted

• Patients before undergoing high-risk elective surgery

Regimen recommended:

• 2% mupirocin ointment three times a day for 5 days -- Prolonged or repeated courses should
be avoided to prevent emergence of mupirocinresistance.

• Chlorhexidine bath or Octenidine wash is also recommended as an alternate.

Low level (MIC 8-256mg/L)

Mupirocin resistant MRSA Treatment success rate of 80%

High level (MIC > 512 mg/L)

Naseptin(0.5%neomycin and 0.1%

Chlorhexidine) four times a day for 10 days

If neomycin resistant – Prontoderm (polyhexamethylene buguanide)

MRSA Clinical Information Records include

37
  All MRSA positive microbiology result (screening, culture or PCR result
etc.)within the last 2 years from the date of request,including the date of test, the
specimen type and the laboratory that performed the test.
 All MRSA screening results (including positive and negative )within the last 2
years from the date of request , including the date of test and the laboratory that
performed the test.

MRSA Tagging

Hospitals should tag all patients who are found to be MRSA positive.

MRSA Untagging

Hospitals can consider untagging patients with a past history of MRSA positivity, if the
patient has either;

 Undergone decolonization with Chlorhexidine bath or Octenidine wash and

Mupirocin nasal cream for at least 5 days is completed in any hospital and 3
negative screening culture from nasal,axillae and groin (NAG),with first sample
at least i week after decolonization therapy.
OR

 If no decolonization, the patient in the hospitalmust meet one of the following

criteria. More than 2 years since the last positive culture3 negative NAG
screening cultures (at least 1 day apart)

VANCOMYCIN RESISTANT ENTEROCOCCI (VRE)

Active surveillance cultures should be undertaken on the following patient groups

1. Patients admitted to high risk areas (ICU,transplantation units)

2. Patients known to be VRE positive, upon re- admission to hospital

3. Patients transferred from other hospitals

4. “At risk “patients who have been contacts of known VRE positive patients.

Laboratory identification

 Rectal swab or faeces is the recommended specimen for surveillance

 Sodium azide agar with 6 µg/ml of Vancomycin or Chromogenic media can be
used for detection of VRE from screening samples, PCR detection of resistant
genes.

Management

 Apply stringent hand hygiene, contact precautions and core strategies including
isolating and cohorting patients,increased environmental cleaning and dedicated
patient equipment.

38
  Gastrointestinal colonization with VRE may persist for long periods of time and
serves as a reservoir for transmission of VRE to other patients.

Hospitals should tag all patients who are VRE and can consider untagging if the patient has
either; more than 2 years since the last positive culture OR 3 negative rectal screening
cultures (at least 1 month apart)

•HCW screening and decolonization is not recommended for VRE.

CRE (CARBAPENEM RESISTANT ENTEROBACTERIACEAE)

Mechanisms of CRE:

I. The production of a broad-spectrum lactamase enzyme(carbapenemase)

2. Increased permeability of the bacterial cell wall for the antimicrobial due to porin loss.

Commonly encountered CRE’s are:

Klebsiella pneumoniae carbapenemase (KPC), New Delhi metallo- β-lactamase (NDM),

Oxacillinase (OXA), Verona Integron-encoded metallo-β-lactamase (VIM) and Imipenemase
Metallo-beta-lactamase (IMP).

Risk Tailors for acquisition of CRE:

•Exposure to broad-spectrum antimicrobials, such as cephalosporins, β lactam-β lactarnase

inhibitor combinations, Fluoroquinolones.

• Prolonged or recurrent hospitalization

• ICU admission

• Presence of central vascular catheters

• Long term urinary catheterization

The gastrointestinal tract is the common site for asymptomatic colonization with CRE in
patients and contaminated hands of healthcare workers have been implicated in hospital
outbreaks of CRE.

Laboratory identification:

• Active surveillance cultures for rectal carriage is recommended for high- risk patient
groups, but not recommended for IICW screening

• Rectal swab or faeces is the recommended specimen for surveillance. Specimens taken from
other sites(urine. swabs from skin breaks or manipulated sites) can also be used.

39
• Chromogcuic media for detection of CRE from stool samples or other rapid tests like
CarbaNP which directly detect carbapenem hydrolysis. PCR for confirmation

When CRE isolate is detected from a clinical specimen on a ward or unit. Surveillance
screening by a rectal swab is recommended for patients with epidemiological link to the
index case.

Patients should be informed of their positive status for colonization or infection.

Treatment:

Decolonization of asymptomatic colonizers of CRE is not recommended as the effectiveness

of treatment is not proven.

References:

1. CDC. Healthcare Infection Control Practices Advisory Committee. Guidelines for control and
prevention of multi-drug resistant organisms (MDROs) in Healthcare facilities, 2013. Atlanta, GA:
US Department of Health and Human Services CDC. Healthcare Infection Control Practices Advisory
Committee; 2014. Available at http://www.cdc.gov/ncidod/dhqp/pdf/ar/mdroguideline2013.

2. NHMRC (2010) Australian Guidelines for the Prevention and Control of Infection in Healthcare,
Commonwealth of Australia.

3. Royal College of physicians/HSE 2012.Guidelines for the Prevention and Control of Multi-drug
resistant organisms (MDRO) excluding MRSA in the healthcare setting.

4. Damani N, Pittet D, Manual of Infection Control and Prevention. University Press, London:
Oxford; 2012.

Antimicrobial Stewardship:

This aims to optimize antimicrobial use among patients in order to reduce antibiotic
resistance, improve patient outcomes and safety, and ensure cost-effective therapy.

At the healthcare facility level, antibiotic stewardship involves:

• Implementing an antibiotic stewardship program; and

• Continuous monitoring and analysis of antibiotic usage, to track changes in antibiotic

resistance and to monitor effects of containment strategies.

Key requirements of a healthcare facility antibiotic stewardship program:

1. A multidisciplinary antibiotic stewardship team with core membership of an infectious

diseases physician (lead doctor) and a clinical pharmacist. Microbiologist, and infection
control professional may also be included.

40
2. Antibiotic stewardship should be available within the healthcare facilities for quality
improvement and patient safety governance structure. There should be collaboration between
the stewardship team and drug and therapeutics and infection prevention and control
committees.

3. Implementation of clinical guidelines that comply with national treatment guidelines and
incorporate changes regularly based on resistance patterns prevailing in the health facility as
reported regularly by microbiology department.

4. Microbiology services reporting patient-specific culture and sensitivity results to optimize

individual antibiotic management.

5. Review of antibiotic prescribing with intervention and direct feedback to the prescriber.

6. Activities according to local priorities and resources & provision of effective & regular
education of prescribers and pharmacists about antibiotic usage, development of resistance
and judicious prescribing of the antibiotics.

7. Point of care interventions including: streamlining or de-escalation of therapy, dose

optimization, parenteral to oral conversion.

8. Use of information technology such as electronic prescribing with clinical decision

support, on-line approval systems.

9. Monitor antibiotic prescribing by measuring antibiotic consumption; drug use evaluations

and using quality & use of Medicine indicators.

10. Support and collaboration of hospital administration including allocation of resources to

provide education and measure and monitor antibiotic usage.

11. Antibiotic stewardship surveillance methods should be established at patient level as well
as population or community level.

Principles for use of antibiotics

1. Before starting any empiric antibiotic treatment, minimum two sets of blood
cultures should be taken from different sites.

41
 2. Prior to initiation of antibiotic therapy, appropriate specimens should be sent for
gram stain and culture. Antibiotic choice must be adjusted according to culture results once
they are available.

3. Antibiotic doses recommended in the various guidelines are for patients with
normal renal and hepatic function only. Dose adjustments should be made for patients with
renal and hepatic function.

4. Convert patients to oral antibiotics once they fulfill the IV-to-PO switch protocol
criteria stated in Fig. 3.

5. Antibiotics marked with asterisk (*) are restricted to ID, Respiratory & ENT
physicians only. For physicians from all other departments, please call ID physician on-call
to approve the empiric use of these restricted antibiotics.

Advantages of oral therapy:

 Drug cost savings

 Ease of administration
 Early discharge opportunity
 Decreased IV-related adverse events

Antibiotics suitable for IV-to-PO conversion (Bioavailability ≥90%):

 Ciprofloxacin (~80%)
 Levofloxacin
 Moxifloxacin
 Clindamycin
 Metronidazole
 Co-trimoxazole
 Fluconazole

42
 Fig: Intravenous-to-oral antimicrobials conversion

Courtesy: Hospital infection control guidelines-ICMR-2016

Empiric use of carbapenems (Ertapenem should not be used for empiric therapy)

43
1.Appropriate criteria A (patients in ICU or HD) (must qualify all)

a. Sepsis

AND

b. Clinically unwell (drowsy/confused, saturation oxygen <92%, systolic blood pressure

<90% OR

Respiratory rate >30 breaths/minute)

AND

c. Onset of infection either nosocomial (>48 hours after admission) OR health care-associated

Sepsis is the systemic response to infection. In sepsis, the clinical signs describing systemic
inflammatory response syndrome (SIRS) are present together with definitive evidence of
infection. SIRS is defined as 2 or more of the following variables:

 Fever of more than 38 ºC or less than 36 ºC

 Heart rate of more than 90 beats per minute
 Respiratory rate of more than 20 breaths per minute or a PaCO2 level of less than 32
mm Hg
 Abnormal white blood cell count (>12,000/µl or <4,000/µl or > 10% bands)
2.Appropriate criteria B (general ward) (must qualify all)

a. Patients with severe nosocomial and health care-associated infections who failed to
improve after 48-72 hours of empiric therapy

AND

b. Appropriate cultures remain negative

Health care-associated infection can be defined as infection in a patient with at least one of
the following risk factors:

 Hospitalization in an acute care hospital for two or more days in the last 90 days;
 Residence in a nursing home or long-term care facility in the last 90 days
 Receiving outpatient intravenous therapy (like antibiotics or chemotherapy) within the
past 30 days Attending dialysis center in the last 30 days

44
3.Appropriate criteria C

Patients with:

a. Febrile neutropenia

b. Severe necrotizing pancreatitis

c. Suspected severe melioidosis

4.Appropriate criteria D

Empiric therapy for nosocomial organ infection when delay in appropriate therapy could pose
catastrophic risk (e.g. mediastinitis, brain abscess etc)

Carbapenem definitive (culture directed) use guideline

1. Ertapenem should be used only for infections caused by ertapenem susceptible

Gram negative bacteria that are resistant to other beta-lactam antibiotics or/and quinolones.

2. Meropenem/Imipenem is preferred agent for Pseudomonas aeruginosa,

Acinetobacterbaumannii and other Gram negative bacteria that are resistant to other beta-
lactam antibiotics (including ertapenem).

3. Carbapenems can be used to treat other infections caused by Gram-negative

bacteria in patients with non-severe allergy and/or intolerance to active penicillins and/or
cephalosporins when isolate is resistant to other classes of antibiotics (e.g. Quinolones).

Antibiotic challenge should be conducted ONLY after consultation with allergy

specialist. (Severe penicillin allergy is defined as bronchospasm, hypotension, angioedema,
urticarial, bullous eruption and Stevens - Johnson syndrome.)

4. It is recommended that carbapenem antibiotics be endorsed by an ID physician within 48

hours of commencement and re-evaluated every 48 hours.

For high end antibiotics such as Colistin, Tigecycline, fosfomycin, daptomycin, etc., they
may be endorsed by an ID physician/physician within 24 hours of commencement and re-
evaluated every 48 hours.

Considerations for use of antibiotics in pregnancy and pediatrics

45
 In pregnancy it is recommended to avoid tetracyclines, quinolones and high dose
Metronidazole (2g).
 Short-term use of trimethoprim (unless low folate status or taking another folate
antagonist such as antiepileptic or proguanil) or nitrofurantoin (at term, theoretical
risk of neonatal haemolysis) is unlikely to cause problems to the fetus.
 Antimicrobial agents in pregnancy and lactation are limited, and antimicrobial agents
should be prescribed with caution.

46
 C. Guideline for Antibiotic Treatment and Prophylaxis:

Common Pathogen 1st Line 2nd Line Comment

Acute viral No Antibiotic Antiviral Symptomatic

infection

Viral with -Betalactam agents 3rd Generation -

secondary infection cephalosporins
-Macrolides

Acute Bacterial - 2nd gen cephalosporin Beta-lactams+Beta- -

infection & 3rd generation lactamase inhibitors
cephalosporins
Carbapenems
st
1 gen Fluoroquinolones
Vancomycin
Aminoglycosides

Mix Bacteria Broad spectrum As per culture -

infection antibiotic of any sensitivity result
generation
Gram+ve, Gram-ve
Aminoglycosides

Mix Anaerobic Broad-spectrum As per culture -

infection antibiotic sensitivity result

Carbapenems

Metronidazole

Cefoxitin

Beta-lactams+Beta-
lactamase inhibitors

Worm infestation Antihelminthics -

Specific or Broad
specific

Fungal Ketaconazole, , With suitable -

Miconazole,Fluconazole Antibiotics

Tuberculosis As policy of DOT’s -

clinic

47
 Amoebic infection Anti amoebics -

Malarial Parasite Chloroquines and Artesunate Resistant cases

Primaquines
Artemether Quinine Derivatives

Note: As per 2017 WHO guidelines Antimicrobials under RESERVE group are: 1.
Aztreonam 2.Cefepime 3.Ceftaroline 4.Polymixin 5. Linezolid 6.Tigecycline 7.
Daptomycin

A. GASTROINTESTINAL & INTRA-ABDOMINAL INFECTIONS

Empiric Alternative
Likely Causative (presumptive) antibiotics/Second
Condition Organisms antibiotics/First Line Line Comments
Viral,
Entero-toxigenic &
Acute Entero-pathogenic
Gastroenteritis E. coli
S. aureus, Rehydration
B. cereus, (oral/IV)
Food poisoning C. botulinum None None essential

Doxycycline 300mg Rehydration

Oral stat (oral/IV)
Azithromycin Oral in Azithromycin 1gm Oralis essential
children (20mg/kg) stat Or Antibiotics are
and pregnant women Ciprofloxacin 500mg adjunctive
Cholera V.cholerae (1g) BD for 3 days therapy.
For
Campylobacter
the drug of
choice
Shigella sp., Ceftriaxone 2gm IV is azithromycin.
Campylobacter, OD for 5 days or oral Antibiotic use
Non- typhoidal cefixime 10-15 associated with
salmonellosis mg/kg/day x 5 days development of
Bacterial Shiga toxin producing Antibiotic Treatment Azithromycin 1g OD x hemolytic
dysentery E. coli not recommended. 3days syndrome.

48
 Add
diloxanid
Metronidazole e
400mg furoate
Oral TDS for 7- Tinidazole 2gm Oral 500 mg
10 OD TDS for
Amoebic dysentery E. histolytica days for 3 days 10days
Metronidazole
250-
500mg oral Tinidazole 2 gm oral
TID x 7- x
Giardiasis Giardia lamblia 10 d 1 dose
Majority
of strains
are
Nalidixic
acid
Outpatients: resistant.
Cefixime Ceftriaxo
20mg/kg/day ne to be
for 14 days or changed
Azithromycin 500 to oral
mg cefixime
BD for 7 days. when
Inpatients: patient is
Ceftriaxone afebrile
2 g IV BDfor 2 to finish
weeks total
+/-Azithromycin Co-trimoxazole 960 duration
S.Typhi 500 mg BD of
Enteric fever S.Paratyphi A mg BD for 7 days for 2 weeks 14days.
Biliary tract infections Enterobacteriacea Ceftriaxone 2gm Imipenem 500mg IV Surgical
(cholangitis, e IV 6hourly or
cholecystitis) (E.coli, OD or or endoscop
Klebsiella Piperacillin- Meropenem 1gm IV ic
sp.) Tazobactam 8hourly interventi
4.5gm IV 8 For 7-10 days on to be
hourly Or considere
Cefoperazone- d if there
Sulbactam 3gm is biliary
IV obstructi
12hourly on.
For 7-10 days High

49
 Metronidazole Severe disease: start
400 mg Vancomycin 250 mg
Hospital acquired oral TDSfor 10 oral
Diarrhea C. difficile days 6h empirically.
Cefotaxime 1-2 Descalate
gm IV TDS Or to
Piperacillin- Ertapene
Tazobactam m 1 gm
4.5gm IV 8 IV
Enterobacteriace hourly Or OD for 5-
ae Cefoperazone- Imipenem 500 mg IV 7 days
(E.coli, Sulbactam 3gm 6hourly or once the
Spontaneous bacterial Klebsiella IV Meropenem 1gm IV patient
Peritonitis sp.) 12h Piperacillin- 8hourly improves
Secondary peritonitis, Enterobacteriace Tazobactam Imipenem 1g IV Source
Intra-abdominal ae 4.5gm IV 8 8hourly control is
abscess/ GI perforation (E.coli, hourly or important
Klebsiella Or Cefoperazone- Meropenem 1gm IV to reduce
sp.), Bacteroides Sulbactam 3gm 8hourly bacterial
(colonic IV or load.
perforation), 12hourly in Doripenem 500 mg If
Anaerobes severe TDS excellent
Infections or source
In very sick Ertapenem 1 gm IV control –
patients, if OD for 5-7
required, addition days;
of cover for yeast other
50
Pancreatitis Entrobacteriaceae, No antibiotics

51
 Piperacillin-
Tazobactam 4.5
gm IV
8 hourly
empirically
Or
Cefoperazone-
Sulbactam 3gm
IV 8
hourly in severe
Infections
In very sick
patients, if
required, addition
of
cover for yeast
(fluconazole iv
800
mg loading dose
day
1, followed by
400 mg
2nd day onwards)
& Imipenem-
Mild- moderate and for Cilastatin 500mg Duration of
Post necrotizing Enterococci, S. Enterococcus IV 6hourly treatment is
pancreatitis: aureus, (vancomycin Or Meropenem based
infected S. epidermidis, /teicoplanin) may 1gm IV on source
pseudocyst; anaerobes, be 8hourly or control
pancreatic Candida Contemplated Doripenem and clinical
Abscess sp. For 7-10 days 500mg IV 8h Improvement
Diverticulitis Amoxycillin-
Mild- Gram-Negative Clavulanate
Bacteria 625mg
OPD treatment Anaerobes TDS for 7 days
Ceftriaxone 2gm
IV
OD
+Metronidazole BL-BLI agents
500 mg IV TDS have very good
or anaerobic
Gram- Negative Piperacillin- Ciprofloxacin + cover, so
Diverticulitis Bacteria Tazobactam 4.5 Metronidazole no need to add
moderate Anaerobes gm IV 8 hourly for 7 days Metronidazole.

52
 empirically
Or Cefaperazone-
Sulbactum 3gm
IV 8
Hourly
Meropenem 1gm
IV
Gram- Negative 8hrly or Imipenem Duration based
Diverticulitis Bacteria Cilastatin 500mg on
Severe Anaerobes IV 6 Hourly Improvement
Ultrasound
guided
Amoxycillin- drainage
clavulanate/ 3rd indicated
Generation in large
Cephalosporin abscesses,
+ signs of
Metronidazole imminent
500mg rupture andno
I.V.TID / 800mg response to
oral Piperacillin- medical
Liver Abscess Polymicrobial TID for 2 weeks Tazobactam IV treatment.

B. CENTRAL NERVOUS SYSTEM INFECTIONS

Empiric antibiotics
Likely Causative (presumptive Alternative
Condition Organisms antibiotics) antibiotics Comments

53
 Antibiotics should be
started as soon as the
possibility of bacterial
meningitis becomes
evident, ideally within
30 minutes. Do not
wait for CT scan or
LP results.
No need to add
vancomycin a primary
agent, as ceftriaxone
Resistant
Pneumococcus is not
common in India.
Listeria is also rare in
India and so
ampicillin
Ceftriaxone Chloramphenic is also not indicated
S. pneumoniae, 2 g IV 12hourly/ ol if Adjust therapy once
H.influenzae, Cefotaxime patient is pathogen and
Acute bacterial Neisseria 2 g IV 4-6hourly allergic to susceptibilities are
Meningitis meningitidis 10-14 days treatment penicillin known.

Staphylococcus
epidermidis,
Staphylococcus
aureus, Meropenem 2gm IV 8
Propionibacterium hourly
acnes, AND
Meningitis-Post- Pseudomonas Vancomycin 15mg/kg
Neurosurgery or aeruginosa, IV 8 May need intra
Penetrating head Acinetobacter hourly ventricular therapy in
Trauma baumanii For 14 days. severe cases

Dexamethasone
Ceftriaxone 2gm IV 0.15mg/kg IV 6
Meningitis with 12 hourlyfor 2-4days (1st
basilar S.pneumoniae, hourly dose with or before
skull fractures H. influenzae For 14 days first antibiotic dose)

54
 Ceftriaxone
2 gm IV 12hourly Exclude TB,
or Nocardia,
Cefotaxime Aspergillus, Mucor
2 gm IV 4-6hourly If abscess <2.5cm &
AND patient neurologically
Metronidazole 1 gm stable, await response
IV to antibiotics.
12hourly Otherwise, consider
Duration of treatment aspiration/surgical
Streptococci, to be drainageand modify
Bacteroides, decided by clinical & antibiotics as per
Enterobacteria- radiological response, Meropenem sensitivity of
Brain abscess, ceae, minimum two months 2gm IV aspirated/drained
Subdural empyema S.aureus required. 8hourly secretions.

C. CARDIOVASCULAR INFECTIONS

Empiric
antibiotics
Likely causative (presumptive Alternative
Condition Organism antibiotics) antibiotics Comments

55
 Penicillin G Vancomycin If patient is stable, ideally
20MU IV 15mg/kg IV waitblood
divided doses, 4 12 cultures.
hourly hourly Antibiotic choice as per
Or (maximum 1g sensitivity
Ampicillin 2gm 12 results.
iv 4h hourly)// Guidance from Infectious
AND teicplani disease
Gentamicin n 12mg/kg IV specialist or clinical
1mg/kg im or iv 12 microbiologist is
8h hourly x 3 Recommended
Duration: 4-6 doses Modify antibiotics based on
weeks followed by 6 culture
Vancomycin - results and complete 4-6
25- 12 mg once weeks of
30 mg/kg daily Antibiotics
loading IV depending
followed upon severity
by 15-20 mg/kg +
IV 12 hourly Gentamicin
(maximum 1gm 1mg/kg IM or
12 IV
hourly)/ 8 hourly
teicoplan
in 12mg/kg IV Duration: 4-6
12 hourly x 3 weeks
doses followed or
by 6 -12 mg Daptomycin
once 6mg/kg IV
daily IV once
Infective depending upon a day
Endocarditis: Viridans severity AND
Native valve Streptococci, Meropenem Duration: 4-6
(awaiting other Streptococci, 1gm weeks
cultures) Indolent Enterococci IV 8h
Infective S.aureus Duration: 4-6 Daptomycin
Endocarditis: (MSSA or MRSA) weeks 6mg/kg IV
Native valve Risk for gram- once
(awaiting negative bacilli a day
cultures) AND
In Severe Sepsis Meropenem
1gm
IV q8h

56
 Duration: 4-6
weeks

14

Infective Daptomycin Antibiotic choice as per

Endocarditis: Vancomycin can sensitivity.
Guidance from Infectious
Prosthetic Valve 15mg/kg IV 12 be used in place disease
of specialist or microbiologist
awaiting Cultures hourly Vancomycin/ is
(maximum Teicoplanin for
1gm recommended.
patients
12
hourly)/ unresponsive to
teicoplan
or intolerant of
in 12mg/kg IV Vancomycin/
Tei
12 hourly x 3 coplanin or
with
doses followed Vancomycin/
by 6 -12 mg Gly
once
copeptide-
daily IV resistant
depending isolates
upon
severity +
Gentamicin
1mg/kg q12h
IV

57
 D. SKIN & SOFT TISSUE
INFECTIONS

Empiric
antibiotics
Likely Causative (presumptive Alternative
Condition Organisms antibiotics) antibiotics Comments
Amoxicillin-
Clavulanate
1.2gm IV
TDS/625 mg
oral
Streptococcus TDS Clindamycin
pyogenes(common), or 600-900mg IV
Cellulitis S.aureus Ceftriaxone TDS Treat for 5-7 days.
S.aureus 2gm
IV OD
Amoxicillin-
Clavulanate
1.2gm IV/Oral
625 TDS
or
Ceftriaxone Clindamycin Get pus cultures before
2gm 600-900mg IV starting
Furunculosis IV OD TDS Antibiotics
Duration – 5-7
days
Early surgical intervention
Necrotizing Streptococcus Piperacillin- Imipenem 1g crucial
Fasciitis pyogenes, S. aureus, Tazobactam IV8hourly
anaerobes, 4.5gm IV or
Meropenem
Enterobacteriaceae 6hourly 1gm
or
(polymicrobial) Cefoperazone- IV 8hourly
Sulbactam 3gm AND
IV 12hourly Clindamycin
600-900mg IV
AND TDS/linezolid
600 mg IV
Clindamycin BD/

58
 daptomycin
600-900mg IV
8 6mg/kg/day
hourly
Duration
depends on the
progress

E. RESPIRATORY TRACT INFECTIONS

Condition Likely Causative Empiric Alternative Comments

Organisms antibiotics antibiotics
(presumptive
antibiotics)

Mild to
Community S. pneumoniae, moderate Piperacillin- If MRSA is a concern, add
case Tazobactam Linezolid 600mg IV/Oral
Acquired H.influenzae, s 4.5gm BD
Legionella, Amoxycillin- IV 6 hourly
Pneumonia
E.coli, Klebsiella sp., 500mg-1 g TDS or If atypical pneumonia
S.aureus oral. Imipenem 1g IV suspected, Doxycycline
If IV indicated, 6hourly 100mg bd
amoxycillin- or or
Azithromycin 500 mg
clavulanate 1.2 g Cefoperazone- oral/IV
Sulbactam 3gm
IV TDS or IV OD
Ceftriaxone 2g
IV 12 hourly
OD
For
Severe cases

Amoxycillin-
clavulanate 1.2 g
IV TDS
OrCeftriaxone 2g
IV OD
Duration 5-8
days

59
 ADD 3-4 weeks treatment
Lung abscess, S. pneumoniae, Piperacillin- Clindamycin required
Tazobactam
Empyema E.coli, 4.5gm 600-900mg IV
Klebsiella sp., IV 6hourly 8hourly
Pseudomonas or
aeruginosa, Cefoperazone-
Sulbactam 3gm
S.aureus, anaerobes IV
12 hourly
Acute
pharyngitis Viral None required As most cases are viral no
antimicrobial therapy
required

Group A ß- In case of Antibiotics are

hemolytic Oral Penicillin v penicillin recommended
to reduce transmission
Streptococci 500mg BD allergy: rates
and prevention of long
(GABHS), or Azithromycin term
Amoxicillin 500 sequaelae such as
Group C, G mg 500mg OD for 5 rheumatic
Streptococcus, Oral TDS for 10 days fever
days or
Benzathine
penicillin 12 lac
units IM stat
Ludwig’s
angina Polymicrobial Clindamycin 600 Piperacillin- Duration based on
Vincent’s (Cover oral Tazobactam
angina anaerobes) mg IV 8 hourly 4.5gm improvement
or IV 6 hourly
Amoxicillin-
Clavulanate
1.2gm
IV
Acute bacterial Viral, Amoxicillin- Moxifloxacin
rhinosinusitis S. pneumoniae, clavulanate 1gm 400mg OD for 5-
oral BD for 7
H.influenzae, days 7days
M. catarrhalis
Acute Viral Antibiotics not - -

60
 bronchitis
required
Azithromycin
Acute bacterial S. pneumoniae Amoxicillin- 500
exacerbation of H. influenzae clavulanate 1gm mg oral OD × 3
oral BD for 7
M. catarrhalis days days
COPD

F. URINARY TRACT INFECTIONS

Asymptomatic bacteriuria NOT to be treated except pregnant women and
immunocompromised patients. All cases of dysuria may not be UTI. Refer to Obstetrics
and gynaecology infections for treatment of asymptomatic bacteriuria in pregnant women.
Empiric
Condition Likely Causative antibiotics Alternative Comments
Organisms (presumptive antibiotics
antibiotics)
E.coli,
Acute Staphylococcus Nitrofurantoin 100 Cefuroxime 250 Get urine cultures before
antibiotics & modify
uncomplicated saphrophyticus(in mg BD for 7 days mg BD for 3-5 therapy
Cystitis sexually or Cotrimoxazole days based on sensitivities.
activeyoungwomen), 960mg BD for 3-5
Klebsiella
pneumoniae days
or
Ciprofloxacin 500
mg BD for 3-5 days

Acute E.coli, Amikacin 1 g OD Piperacillin- Urine culture and

uncomplicated Staphylococcus IM/IV Tazobactam 4.5g susceptibilities need to be
Pyelonephritis saphrophyticus (in or IV 6 hourly collected before starting
sexually active
young Gentamicin 7 or antimicrobial treatment to
women), mg/kg/day OD Cefoperazone- guide treatment.
Klebsiella Sulbactam 3g IV

61
 pneumoniae,
Proteus mirabilis (Monitor renal 12 hourly
function closely
and or
rationalise
according Ertapenem 1 g IV
to culture report) OD
Complete total
duration of 14 days
Complicated Escherichia coli, Piperacillin- Imipenem 1g IV 8 Get urine cultures before
Klebsiella
Pyelonephritis pneumonia, Tazobactam 4.5gm hourly antibiotics & switch to a
narrow spectrum agent
Proteus mirabilis, IV 6 hourly or based
on sensitivities. Treat for
Pseudomonas or Meropenem 1gm 10-
aeruginosa, Amikacin 1 g OD IV 8 hourly 14 days.
Enterococcus sp. IV
or De-escalate to Ertapenem 1
Frequently multi-
drug Cefoperazone- gm IV OD, if
resistant organisms
are Sulbactam 3gm IV Imipenem/meropenem
present 12 hourly initiated.
Monitor renal function if
aminoglycoside is used.
Doxycline 100 mg In severe cases,
Acute
prostatitis Enterobacteriaceae BD Piperacillin- Get urine and prostatic
(E.coli, Klebsiella
sp.) or Tazobactam massagecultures before
Co-trimoxazole antibiotics & switch to
960 4.5gm IV 6 narrow
mg BD. hourly spectrum agent based on
or sensitivities and then treat
Cefoperazone- total for 3-4 weeks.
sulbactam 3gm IV Use Ciprofloxacin (if
12 hourly sensitive)
or
Ertapenem 1 gm
IV OD
or
Imipenem 1g IV 8
hourly

62
 or
Meropenem 1gm
IV 8 hourly

G. OBSTETRICS AND GYNAECOLOGICAL INFECTIONS

 Fluoroquinolones are contraindicated in 1st trimester.
 Cotrimoxazole is contraindicated in 1st trimester.
 Doxycycline is not recommended in nursing mothers. If need to administer
doxycycline discontinuation of nursing may be contemplated.

Primary
Infections Likely organism treatment Alternate Remarks
(presumptive Treatment
antibiotics)
Screen in 1st
Asymptomatic Nitrofurantoin 100 Oral trimester.
m Can cause
Bacteriuria g Oral, BD for 7 cephalosporins, pylonephritis
> 1,00,000 cfu/ ml TMP-SMX or
of days TMP in upto 25% of all
bacteria of same or Amoxicillin 500 Alone pregnant women.
species in 2 urine mg Oral BD 30 % Chance of
cultures obtained
2-7 x 7-10 days . recurrence after
empirical therapy 1.
days apart. Few
direct effects,
Treat as per uterine
sensitivity result hypo perfusion due
for 7 to
days. maternal anemia
dehydration, may
cause
fetal cerebral hypo
perfusion.
2. LBW,
prematurity,premat
ure
labour,

63
 hypertension,
preeclampsia,
maternal
anemia, and
amnionitis.
Need to document
pyuria (Pus cells >
10/HPF)
Cefazolin 2 gm Prevalance very low
Group B Group B Streptococci IV Penicillin G 5 IV so
(Loading Dose) the prophylaxis may
streptococcal million units. and be
Disease, (Loading dose) required only on
Prophylaxis then then 1 gm TID culture
and Treatment 2.5 -3 million units documented report
Associated with
IV QID until high
delivery. Clindamycin 900 risk of pre-term
labour,still
or mg IV TID or birth,neonatal
Ampicillin 2 gm
IV vancomycin IV or sepsis
( Loading dose)
then teicoplanin for
1 gm QID until penicillin allergy
delivery
Group B streptococcus, Gram negative Preterm Birth, 9-
Chorioamnionitis bacilli, Clindamycin/ 11%
chlamydiae, ureaplasma and anaerobes, death rate in
usually vancomycin/ preterm
infant’s
Polymicrobial teicoplanin and unfavourable
neurologic
cefoperazone- outcome,
Sulbactum lesser risk to term
infants.
If patient is not in
sepsis then IV
Ampicillin
Bacteroides, Prevotella
bivius, Ampicillin 500 Ceftriaxone 2g IV
Septic abortion Group B, Group A mg QID + OD
Streptococcus, Metronidazole
Enterobactereaceae, C. 500mg IV TDS

64
 if
trachomatis,
Clostridium patient has not
perfringens. taken any prior
antibiotic (start
antibiotic after
sending
cultures)
If patient has
been
partially treated
with antibiotics,
send blood
cultures and
start
Piperacillin-
Tazobactam or
Cefoperazone-
sulbactam till
the
sensitivity
report
is available.

Bacteroides, Prevotella
Endomyometritis bivius, Same as above.
and Septic Pelvic Group B, Group A
Vein Phlebitis Streptococcus,
Enterobactereacea
e, C.
trachomatis, Clostridium
perfringens
Obstetric Sepsis Group A beta-haemolytic If patient is in
during pregnancy Streptococcus, shock and blood
culture reports
E.coli, anaerobes. are
pending, then
start
Piperacillin-
Tazobactam or
Cefoperazone-
sulbactam till
the
sensitivity

65
 report
is available and
modify as per
the
report. If patient
has only fever,
with no features
of severe sepsis
start amoxicillin
clavulanate oral
625TDS/IV 1.2
gm TDS Or
Ceftriaxone
2gm
IV OD+
Metronidazole
500mg IV TDS
+/-gentamicin
7mg/kg/day OD
if
admission
needed.
MRSA cover
may be required
if
suspected or
colonized
(Vancomycin/
Teicoplanin)
Obstetric Sepsis S. pyogenes, Same as above Sources of sepsis
following outside Genital
pregnancy E. coli, tract
S. aureus Mastitis
S. pneumoniae, UTI
Meticillin-resistant Pneumonia
S. aureus Skin and soft
(MRSA), tissue
C. septicum & (IV site, surgical
Morganella site, drain site
morganii. etc.)

Refer to STD
Syphillis program

66
 guidelines
Please refer RNTCP Very small chance
Tuberculosis in Similar to NON guideline of
transmission of
Pregnancy PREGNANT infection
WHO has advocated that, all the first line
population with drugs are to fetus.
some exceptions safe in pregnancy and can be used except
(see comment streptomycin. SM causes significant
and ototoxicity to
the fetus (Pyrazinamide not recommended
chapter 8) by US
FDA)
1. Mother and baby should stay together and
the
baby should continue to breastfeed. Late diagnosis can
2. Pyridoxine supplementation is
recommended for predispose to LBW,
all pregnant or breastfeeding women taking prematurity.
isoniazid as well as to neonate who are
being breast
fed by mothers taking
INH.

VIRAL INFECTIONS (NO ANTIBIOTICS TO BE GIVEN)

1. Tendency for Direct fetal

Influenza In severe infection
Oseltamivir 75 mg including premature
Pregnancy Oral Nebulization with labor rare
(seasonal And BD for 5 days Zanamvir respules (2) &delivery.
H1N1) 5 mg each, BD
Preterm delivery
for 5 days 2. Treatment should and
begin within 48 hrs
The best of pregnancy loss.
Preventive onset of symptoms.
strategy is
administration
of 3. Higher doses
commonly used in
single dose of non
killed vaccine. pregnant population

67
 (150
mg) are not
recommended in
pregnancy due to
safety
concerns.
4. Chemoprophylaxis
can
be used in significant
exposures.
5. Live (nasal
Vaccine) is
contraindicated in
pregnancy.

VZIG should be offered to susceptible Chickenpox

Varicella >20 wks of gestation, women < 10 during
days of the exposure. VZIG has no role in pregnancy does
presenting within 24 treatment not
hours of the onset of justify
the once the rash appears. termination
without prior
rash, prenatal
The dose of VZIG is 125 units / 10kg not
exceeding diagnosis as only.
Aciclovir 800mg Oral
5 625 units, IM.
A minority of
times a day fetuses
infected develop
IV acyclovir fetal
varicella
recommended for the syndrome.
treatment of severe
complications,
> 24 hrs from the
onset
of rash, antivirals are
not
found to be useful.

PARASITIC INFECTIONS

Acute <18 weeks gestation at diagnosis

68
Toxoplasmosis
in pregnancy Spiramycin 1 gm Oral qid until 16-18
weeks/Pyrimathamine + sulphadizine.
Alternate every
two weeks–
20

If PCR Positive -
>18 weeks gestation and documented fetal
infection by
positive amniotic fluid PCR.
Pyremethamine 50 mg Oral BD x 2 days then
50 mg
OD
+
Sulphadiazine 75 mg/kg Oral x 1 dose then
50mg/kg
Bd
+
Folinic Acid (10-20 mg Oral daily) for
minimum of 4
weeks or for duration of pregnancy.
As per national
Malaria In program
Pregnancy

GENITAL TRACT INFECTIONS

Non-pregnant-
Candidiasis Candida species Fluconazole oral 150 mg single dose If
recurrent
For milder cases- candidiasis,
Intravaginal agents as creams or suppositories (4 or more
episodes/year)
clotrimazole, miconazole, nystatin. 6
months
Intravaginal azoles, single dose to 7-14 days. suppressive
treatment with
fluconazole
150 mg
oral once a
week or
clotrimazole
vaginal

69
 suppositories
500 mg
once a week.
Treat the
Bacterial Polymicrobial Metronidazole500mg Oral BD x 7 days partner.
Vaginosis Or metronidazole vaginal gel 1 HS x 5 days
Or Tinidazole 2 g orally ODx 3 days Or 2%
Clindamycin Vaginal cream 5 gm HS x 5 days
Trichimoniasi Trichomonas Metronidazole 2 gm single dose or 500 mg
s vaginalis Oral BD X
Treat sexual
7 days or partner
with
metronidazole
2
Tinidazole 2 gm Oral single doseFor treatment gm single
failure dose
– retreat with Metronidazole 500 mg Oral BD
X7
Days, if 2nd failure Metronidazole 2 gm Oral
OD X 3-
5 days
Ceftriaxone 250 mg IM Single dose +
Cervicitis Azithromycin 1
gm single dose OR Doxycycline 100mg BD x
/Urethritis Polymicrobial 7 day
Mucopurulent
Gonoccocal
Drainage of
Pelvic S. aureus, Outpatient treatment tubo-
ovarian
Inflammatory Enterobacteriacae, Ceftriaxone 250 mg IM/IV single dose plus +/- abscess
Metronidazole 500 mg BD x 14 days Plus wherever
Disease gonococci, gardenella Doxycycline indicated
Evaluate and
(Salpingitis & 100 mg BD x 14 Days treat sex
Inpatient Treatment Clindamycin +ceftriaxone
tubo-ovarian till partner
abscess) patient admitted then change to OPD treatment
Amoxycillin clavulunate/Cephalexin 500 mg
Mastitis S. aureus QID/ OR
without
abscess Ceftriaxone 2 gm OD OR
MRSA- based on sensitivities Add

70
 Clindamycin 300 QID or
Vancomycin I gm IV 12 hourly /teicoplanin
12mg/kg
IV 12 hourly x 3 doses followed by 6 once
daily IV
Mastitis with Drainage with antibiotic cover for
Abscess MRSA
Clindamycin 300 QID or
Vancomycin 15mg/kg IV 12 hourly (maximum
1gm 12
hourly)/teicoplanin 12mg/kg IV 12 hourly x 3
doses
followed by 6 mg once daily IV
2
1

H. BONES AND JOINT INFECTIONS

Condition Likely causative Empiric antibiotics Alternative Comments

Organisms Antibiotics
Treat based on
Acute S.aureus, Ceftriaxone 2g IV OD Piperacillin- culture of
osteomyelitis blood/synovial
OR Streptococcus Tazobactam fluid/bone
Followed by Oral 4.5gm IV q 6h
Septic arthritis pyogenes therapy by or Biopsy
Enterobacteriaceae Cloxacillin 500mg q 8h Cefoperazone-
Orthopedic
Or sulbactam 3gm Consultation
is essential for
Cephalexin 500mg q 6h IV q 12h surgical
AND Debridement
Clindamycin
600-
900mg IV TDS Duration: 4-6 weeks
(From initiation or
last
major debridement)
Chronic No empiric therapy Definitive
Osteomyelitis treatmentguided by

71
 bone/synovial
OR biopsy
Chronic
synovitis culture.
Treat for 6 weeks
Minimum
Investigate for TB,
Nocardia, fungi.
Extensive surgical
debridement.
Total duration of
treatment depends
on the
joint and the
organism.
Choose antibiotic
based
on sensitivity.

Ceftriaxone 2g IV OD.
Prosthetic joint Coagulase negative Add 4 weeks
Vancomycin1gm IV BD
Infection staphylococci, or
Staphylococcus Teicoplanin 800mg x 3
doses followed by
aureus,Streptococci 400mg
Gram-negative
bacilli, Once daily
Enterococcus,
Anaerobes

I. EYE INFECTIONS

Likely
Eyelid infections organisms First line/ Suggested Alternate regimen Remarks
Regimen
Blephritis
Unclear Lid margin care with baby
shampoo & warm
S.aureus, compresses

72
 24 hourly. Artificial tears
S.epidermidis if
associated with dry eye.

External
Hordeolum S. aureus Hot pack

Internal
Horedeolum

Oral Cloxacillin 250-500

MSSA/ mg
Blephritis S. epidermidis qid or
Oral Cephalexin 500mg
QID Lid margin care with
baby shampoo &
warm
compresses 24
MRSA Oral Trimethoprim hourly.
sulphamethoxazole960 mg Artificial tears if
associated with dry
BD or eye.
Linezolid 600mg BD

Cunjuctival
infections
No antibiotics required Highly
treat contagious.
Viral conjunctivitis for symptoms If pain &
photophobia
(pink eye) the
suggestive of
keratitis.
Uncommon
Bacterial S.aureus, Ophthalmologic solution: causes-
Gatifloxa
conjunctivitis S.pneumoniae, cin 0.3%, Chlamydia
levofloxa
H.influenzae cin 0.5%, Trachomatis
Moxifloxacin 0.5% 1-2 N.gonorrhoe
drops ae

73
 q2h while awake during
1st 2
days, then q4-8h upto 7
days
Corneal infections
Trifluridine ophthalmic Flurescine
Herpes Simplex soln Ganciclovir 0.15% staining
shows
Keratitis H.simplex type 1drop 2 hourly, up to ophthalmic gel for topical
9times/day until re- acute herpitic
1&2 epithilised. keratitis. Dendritic
then 1 4 hourly upto figures.30-
drop 5 50%
times/day for total recur within
duration of 2yr.
21days

Varicella Zoster Varicella–zoster Famciclovir 500mg BD Or Acyclovir 800mg 5

ophthalmicus virus TID OR Valacyclovir 1gm times/d x 10days .
oral TID X 10days
Moxifloxacin Moxifloxaci
Acute bacterial S.aureus, topical(0.5%):1 Gatifloxacin 0.3% n.
keratitis (No S.pneumoniae, drop 1 hourly for first ophthalmic Solution Preferable.
1drop 1 hourly for Treatment
comorbidities) S.pyogenes, 48hr,then reduce as per 1st may fail
against
Haemophilus spp response 48hrs then reduce as MRSA.
per response
Tobramycin or
Acute Bacterial P.aeruginosa Gentamicin Ciprofloxacin
(Contact lens users) 14mg/ml + Piperacilin or ophthalmic 0.3% or
Ticarcillin eye drops (6- Levofloxacin

12mg/mL) q15-60 min

around
the clock 24-72hr,then
slowly

reduce frequency

Natamycin (5%) 1drop Empirical

Fungal keratitis Aspergillus, 1-2 Amphotericin B therapy
Fusarium, hourly for several (0.15%) 1 drop q1-2 is not

74
 days,then 3-
Candida and hourly for several
others 4 hourly for several days days recommended.

depending on response depending on the

Response
Acanthamoeba Optimal regimen Uncommon.Tr
Protozoan spp. uncertain - aum
Suggested – a & soft
(soft contact lense (Chlorhexidine contact
users) 0.02% or lenses are risk
Polyhexamethylenebigua
nide factors

0.02%) +

(Propamidineisethionate
0.1%or Hexamidine
0.1%)

eye drops 1drop every 1

hourly hourly during day
time,
taper according to
clinical

response

Orbital infections
Cloxacillin 2 gm IV
Orbital cellulitis S.pneumoniae, q4h+ If If MRSA is
Ceftriaxone 2 gm IV Pencillin/ suspected
H.influenzae, q24 Cephalospori substitute
hourly+ Metronidazole
M.catarrhalis, 1gm n allergy: cloxacillin with

S.aureus, IV 12h Vancomycin 1gm iv Vancomycin

Anaerobes, q12h + levofloxacin

750 mg IV once daily
Group A +

Streptococcus, Metronidazole iv 1gm

Occasionally
Gram 24h

75
 Negative bacilli
post trauma.

Post-ocular S.epidermidis
surgery
Endophthalmits Immediate Adjuvant
systemic
Bacterial S. aureus, Streptococci, ophthalmological
antibiotics
enterococci, Gram- consultation. ( doubtful value
negative in
Bacilli Immediate
vitrectomy+ post cataract
intravitreal antibiotics
surgery
(Inj Vancomycin + Inj endophthalmitis
)Inj
ceftazidime) Vancomycin+
Inj
Meropenem

Hematogenous S.pneumoniae,
N.meningitidis,
S. aureus,
Group B streptococcus,
K. pneumoniae

76
 Intavitreal amphotericin
B
Endophthalmitis Candida sp, 0.005-0.01 mg in 0.1 ml
Mycotic (Fungal) Aspergillus sp. Systemic therapy:
Amphotericin B 0.7-
1mg/kg +
Flucytosine 25mg/kg qid

Liposomal Duration of
Amphotericin B 3- treatment 4-6
5mg/kg weeks or longer
J. EAR INFECTIONS Or depending upon
Likely clinical
Ear Etiolog Suggested Alter Voriconazole response.
Patients with
infection y/ Regimen nate Remarks
chorioretinitis
Malignant P. Debridem
and ocular
otitis aerugin Piperacilin+ Ceftaz ent
involvement
externa osa (in Tazobactam idime usually
>90% 4.5gm IV required.
cases) 6h Or Rule out
osteomyel
Imipenem/ itis; Do
Meropenem CT or
MRI, If
Ciprofloxac bone
in involved ,
treat for
4-6 wks.
S. Treat
pneum children
oniae <2 years
If >2
Acute H. Amoxicillin years,
otitis influen +clavulanat Ceftri afebrile
media zae e axone and
90/6.4mg 50mg/ no ear
Morexe /kg/day bid kg pain-
lla or I/M consider

77
 catarrahalis cefpodoxim /cefuroxime for 3 days analgesics and defer
axetil 250mg BD Antibiotics
Duration of treatment
If age <2 years: 10
days
If age >2 years : 5-7
Days
Mastoiditis
Acute S.pneumoniae
Cefotaxime 1-2 gm iv 4-
S.aureus 8 Modify as per culture
H.infiuenzae hourly Unusual causes-
P.aeruginosa Ceftriaxone 2 gm iv OD Nocardia, TB,
Actinomyces.
Piperacillin- tazobactam
Chronic Polymicrobial 4.5g
IV 8h
Meropenem 1 gm iv 8h
Acute
Pharyngitis/tonsillitis
Exudative/Diffuse Mostly viral Penicillin allergic,
Penicillin V oral x10
Erythema Group A, C, G days or Clindamycin 300-450
mg orally 6-8 hourly
Streptococcus, Benzathine Penicillin 1.2 x5
MU IM x 1 dose or
Infectious Cefdinir days. Azithromycin
mononucleosis, or cefpodoxime x 5 days clarithromycin are
alternatives.
Membranous
pharyngitis C.diptheriae, Erythromycin 500 mg IV
QID or Penicillin G
50,000
units/kg IV 12 hourly.
Diptheria antitoxin:
Horse
serum.
<48 hrs:20,000-40,000
units,
Nasopharyngeal
membranes:40,000-
60,000
units

78
 >3 days & bull neck :
80,000-1,20,000 units

Levofloxacin
Epiglotitis(Supraglotis Cefotaxime 50 mg/kg IV
) Children: 8 10 mg/kg IV
H.influenzae , hourly or ceftriaxone 50 24 hourly +
S.pyogenes, mg/kg IV 24 hourly clindamycin
7.5 mg/kg IV
S.pneumoniae, 6
S.aureus. hourly.
25

Adult: Group A
Streptococcus ,
H.influenzae
Laryngitis(hoarseness
) Viral (90%) No antibiotic indicated

K. INFECTIONS IN BURNS PATIENTS

Likely
Condition Causative Empiric antibiotics Alternative Comments
Organism antibiotics

For burns wound that Prophylactic

is parenteral
antibiotics in burns
clinically or are
microbiologically not NOT indicated
Infected
Topical antibiotics to
be
given after
debridement

For burns wound that i. Burn wound

are Strep pyogenes, sepsis Antibiotic choices are

79
 Enterobacter Pipercillin-
clinically or sp., tazobactam Carbapenem dependent on the
microbiologically
infected S. aureus, or +/- antibiogram of the
Cefoperazone- Vancomycin
S. epidermidis, sulbactam / individual institution.
Pseudomonas, or Teicoplanin
Surgical debridement
fungi (rare) With or without: as
 Vancomycin necessary.
Amphotericin B is
//Teicoplanin toxic
(if there is suspicion for to all burn patient as
MRS
A) renal system
compromised, hence
 Antifunal Therapy – Caspofungin may be
extensiv
When e burns used.
and patient not
responding to
antibiotics
If haemodynamically
stable : fluconazole
If haemodynamically
unstable : Echinocandin
Burn wound Cllulitis
Cefazolin or
clindamycin or
vancomycin if there is
suspicion for MRSA
with and without (for
burns involving the
lower extremity or feet
or burns in patients
with diabetes)
Piperacillin-tazobactam
or cefoperazone
sulbactam

h. SVIMS hospital implements the antibiotic policy and monitors rational use of
antimicrobial agents*

80
SVIMS hospital has released Antimicrobial Stewardship Pocket guide and it is revised every
six months & uploaded in the SVIMS website.

ANTIMICROBIAL STEWARDSHIP (AMS PROGRAMME)

 Objectives: To provide the importance of antimicrobial stewardship programme and

challenges while implementing the programme in the hospital and their solutions.

 It provides the necessary recommendations to the healthcare workers in hospitals to

improve the quality of antibiotic prescribing and thereby improve patient clinical
outcomes.

WHY TO IMPLEMENT ANTIMICROBIAL STEWARDSHIP IN HOSPITALS?

Antimicrobial resistance (AMR) is a rising threat cross the global. There is a dramatic
increase in the antimicrobial resistance in the recent days and many of those are multidrug
resistance (MDR). The multidrug resistance organisms (MDROs) are prevalent in each and
every country though the extent and the severity of the problem vary.

Misuse and over-use of antibiotics

Since the discovery of penicillin, there have been widespread use of antibiotics In hospital
and community settings, Though last seven decades witnessed that the antibiotics were highly
effective and have saved millions of lives, at the same time, this has also led to their misuse
through various ways such as use without a prescription and overuse for self-limiting
infections, non-bacterial infections and treatment of colonization.

Antibiotics are used in various sectors, Interesting fact is world’s largest antibiotic use occurs
for animal no-therapeutic purpose(70%), followed by animal therapeutic purpose)15%),
Human use accounts for only 15% of total antibiotic consumption out of which only 9% are
used for human therapeutic purpose. This date explains that just brining is stewardship
programme in health care facility won’t bring down antibiotic use dramatically, A robust plan
should also be in place for control of antibiotic use in animals.

Poor antibiotic research and development

Unfortunately there are not many researches going on for the development of newer
antibiotics especially when it comes to antibiotics active against Gram-negative bacteria.
Research and development of any antibiotic is a huge investment for the pharmaceutical
industry. More so, soon after the discovery of the antibiotic, the bacteria develop resistance
mechanisms to tackle the antibiotic. As a result the investment goes waste, Lack of
profitability has forced pharmaceutical industry to graze in fresh meadows, leaving the field
of anti-infective research quite barren, That is also hypothesized that there could be a return
to the pre-antibiotic era, where many people could suffer or die from untreatable bacterial
infections.

81
 33%
32%
30%
16%
20% 10%
6%
Human non- 10%
therapeutic 0%
9% Human ther-
apeutic
15% Series1
Animal ther-
apeutic
70% Animal non-
therapeutic

Fig-1 Current use of antibiotics in the world Fig-2: Unnecessary Antimicrobial therapy

Antimicrobial prescribing Facts: The 30% rule

Hoffman et al in 2007 have described that Antimicrobial prescribing facts follow 30% rule.
Although there is no clear cut data available for India, but it is believed that the situation is
same or even worse in Indian scenario.

 Nearly 30% of all hospitalized inpatients at any given time receive antibiotics
 Over 30% of antibiotics are prescribed inappropriately in the community
 Up to 30% of all surgical prophylaxis is inappropriate
 About 30% of hospital pharmacy costs are due to antimicrobial use
 10 – 30% of pharmacy costs can be saved by antimicrobial stewardship programs

ANTIMICROBIAL STEWARDSHIP

Antimicrobial stewardship (AMS) is one of the key strategies to overcome antimicrobial

resistance. It involves the careful, judicious and responsible management of antimicrobial
use.

Definition

There are many ways ofAntimicrobial stewardship can be defined.

“Antimicrobial stewardship” is an inter-professional effort, across the continuum of care

involves timely and optimal selection, dose and duration of an antimicrobial for the best
clinical outcome for the treatment of prevention of infection with minimal toxicity to the
patient and minimal impact on resistance and other ecological adverse events such as
Clostridium.difficile’ [Nathwani et al., 2102] CDC has defined“Antimicrobial stewardship”
as-

 The right antibiotic

 for the right patient,
 At the right time.

82
  with the right dose, and
 the right route, causing
 the least harm to the patient and future patients
(www/cdc.gov/getsmart/healthcare/inpatient-stewardship)

1. Goals of Antimicrobial stewardship

 Restricting antibiotics results in reduction of antibiotic pressure which in turn
prevents the development of antimicrobial resistance.
 Restricting antibiotics can reduce colonization or infection with Gram-positive or
Gram –negative resistance bacteria.

2. Goal 2: Improve patient outcomes

* Improve infection cure rates

* Reduce surgical infection rates

* Reduce mortality and morbidity

3. Goal 3: Improve patient safety

 Reduce antimicrobial consumption, without increasing mortality or infection-related

readmissions e.g.22% - 36% reduction in antimicrobial use [Dellit et al ., 2007]
 Reduce C.difficile colonization or infection by controlling the use of “high –risk
“antibiotics[Valiquette et al., 2007]

4. Goal 4:Reduce healthcare costs towards antimicrobial expenditure without adversely

impacting quality of care

IMPLEMENTATION OF ANTIMICROBIAL STEWARDSHIP PROGRAM

The six steps of Antimicrobial stewardship programme (AMSP) are depicted in table-1.

Table-1-Key steps for implementing an Antimicrobial stewardship programme (AMSP)

1. Administrative support (Leadership)

2. Assess the situation
 Supporting infrastructure
 Supporting manpower
3. Set up AMS team
4. Frame Antimicrobial policy-Hand book with system wise indications
5. Implement AMS strategies
 Front end strategies – Formulary restrictions
 Back end strategies – Antimicrobial review methods (prospective audits and
pharmacy driven AMSP)
6. Educate and train

Step-1: Administrative support (Leadership)

83
The most important prerequisite for implementing AMSP is a strong administrative support.
None of the efforts of ID physicians, Microbiologists, or infection control specialist to
establish AMSP are likely to be successful without active involvement by hospital leadership.
The role of administrators’ are-

 Publicly committed to the program –Hospital administrators should play a front role
and show leadership quality while implementing AMSP. Many a times, it is observed
that AMSP is initiated by ID physicians or microbiologists, or infection control
specialists and they try to convince the administrators to provide a passive support.
All those attempts often fail because stakeholders of the program will be adhering to
the policy guideline.
 Program funding – Without adequate support form hospital leadership, program
funding will be inadequate or inconsistent since the programs do not generate
revenue although they may result in significant cost savings.
7. Freedom and power to AMS team – Hospital administrators should provide the
liberty, freedom and power to the members of antimicrobial stewardship team to
execute the policy.

Step – 2: Assess the situation

The hospital administrators should analyse the situation and what problems they want to
address. There are many international guidelines available but those need to be adapted
them to the local situation. Define where you are and where you want to go, with
quantitative figures. The followings should be assessed first before implementing AMSP.

2 A) Assess the diagnostic support available-

Availability of a rapid microbiology diagnostic tools and biomarkers is recognized as a

key intervention in implementation of antimicrobial stewardship in hospitals. The
diagnostic facility should be improved first before start implementing AMSP in the
hospitals. However, the availability of these facilities in resource-limited hospitals is
likely to be a challenge to their introduction. But the administrators should realize that
additional budget needed for these investigations will be much lesser compared to the
cost saving which can be achieved by rationalizing the use of antibiotics.

A. Complete automation of microbiology – This is an essential requirement before

implementing will achieve better clinical outcomes and timely streamlining /de-
escalating of empiric broad – spectrum antibiotics in seriously ill patients. The various
diagnostic facility available are –
o Culture automation-BACTEC or BacT/Alert
o Identification automation – AMALDI-TOF
o Antibiotic susceptibility testing automation – by Phoenic or Vitek ( it gives
results in MIC which is more reliable and accurate then disk diffusion
method)

84
B. Rapid Identification systems Such as near-patient rapid tests can be revolutionized.
For example, bed side rapid tests for influenza and Strep A can be useful to identify
patients with bacterial versus viral infections.
C. Rapid molecular diagnostic screening tests play an important role in pathogen
detection in critically ill patients which will improve antibiotic stewardship and
clinical outcomes.

Film array (biomerieux system – It is an FDA, CE-IVD, and TGA certified multiplex
PCR system that integrates sample preparation, amplification, detection and analysis.
This simple system requires just 2 minutes of hands-on time, with a total run time of
about an hour.
1. Respiratory panel : tests for a comprehensive panel of 20 respiratory viruses
and bacteria
2. Blood Culture identification panel: tests for a comprehensive list of 24
pathogens and 3 antibiotic resistance genes associated with bloodstream
infections.
3. Gastrointestinal Panel: tests for 22 common gastrointestinal pathogens
including viruses, bacteria and protozoa that cause infectious diarrhea.
4. Meningitis Encephalitis Panel : tests directly in CSF for the 14 most relevant
ME –associated pathogens including bacteria, viruses and a parasite

D. Biomarkers for sepsis e.g. Procalcitonin – Procalcitonin (PCT) has been used as a
rapid testing biomarker of bacterial infection, a very important interventional tool for
antibiotic stewardship. There are several biomarkers that are used to guide initiation,
and stop of antimicrobial therapy.

Biomarkers Role in AMSP

IL-6 Show a fast initial spike upon infection with, however, levels going
back to normal within a few hours. The high variability of these
markers has been a major challenge for their use in clinical practice.
C-Reactive Increases slowly with a peak after 48 – 72 hours and show decrease
protein thereafter. CRP is usually considered a biomarker for inflammation
(CRP) rather than infection.
Procalcitoni It is detectable within 2 – 4 and peaks within 6 – 24 hours and
n (PCT) decreases daily by around 50% if the bacterial infection is controlled
by the immune system supported by effective antibiotic therapy. These
characteristics make PCT an interesting biomarker for monitoring
patients with systemic infections and sepsis and for more informed
decisions on prescription and duration of antibiotic therapy. As PCT
levels do not show a steep decrease in non-responding infections,
monitoring its course also has prognostic implications.

85
 Figure -3: Biomarkers raised following bacterial infection

Procalcitonin

Procalcitonin is a prohormone of the calcium homeostasis hormone calcitonin.

 Normally, it is produced I the Neuro-endocrine medullary C –cells of the thyroid

gland at a very low concentrations (<0.05 ng/ml)
 Bacterial infections selectively induce an increase in the concentration of PCT ( in
multiple parenchymal tissues ) because both endotoxins (lipopolysaccharide) form
the bacterial cell wall and host responses to infection stimulate the production of PCT
by cytokines, such as IL-1β,IL-6 TNFα.
 The up-regulation of PCT correlates with the severity and extent of bacterial
infections.
 This results in an accumulation of PCT because, unlike neuroendocrine cells,
parenchymal cells lack the ability to cleave procalcitonin into its mature form,
calcitonin.
 Conversely,Interferon-γ,a cytokine released in response to viral infections (marker of
CMI), blocks the up regulation of PCT, resulting in a higher specificity of PCT
toward bacterial infections.
Thus, PCT helps to distinguish severe bacterial infections from milder viral illnesses.

 PCT production is not impaired by neutropenia or other immunosuppressive states.

 PCT levels parallel the severity of the inflammatory insult or infections meaning those
with more severe disease have higher levels.
 Furthermore, procalcitonin has some utility as a prognostic indicator with higher
serum concentrations related to the risk of mortality.

86
  Advantage over CRP and WBC count : These advantages include specificity for
bacterial infection, the rapidity of its rise after an insult (6h), the rapid decline with
immune control on infection (half life of 24 h), excellent correlation with severity of
illness (higher levels in more severely ill), and the lack of impact to anti-inflammatory
and immunosuppressive states on production.
PCT is used as a guide in the following situations:

1. Differentiation of bacterial verses viral respiratory tract infection.

2. Determination of the duration of antibiotic treatment in respiratory infections.
3. Diagnosis and monitoring of sepsis and septic shock.
4. Prognostic usefulness in classifying the patients as low risk or high risk for
bacterial infection and /or sepsis and prediction of mortality.
5. Monitoring the response to antibacterial therapy.
6. Differentiating bacterial verses viral meningitis.
7. Diagnosis of bacterial infection in neutropenic patients.

Importance of Interpreting Susceptibility Reports (disk diffusion and MIC) for AMSP

Determination of the antimicrobial susceptibilities of significant bacterial isolates is

one of the principal functions of the clinical microbiology laboratory. From the
physician’s pragmatic point of view, the results of susceptibility tests are often
considered important or more important than the identification of the pathogen
involved. This is particularly true in an era of increasing antimicrobial resistance, in
which treatment options are at times limited to newer, more costly antibacterial
agents.

High priority has to be given not only to producing technically accurate data but also
to reporting those data to physicians in an easily interpretable manner. Result is
generally reported as category:

“Susceptible” – Implies that there is a high probability that the patient will respond to
treatment with the appropriate dosage regimen for that antimicrobial agent.

“Intermediate” (buffer zone) – With agents that can be safely administered at higher
doses or that the agent may prove efficacious if it is normally concentrated in an
infected body fluid, e.g., urine Conversely, for body compartments where drug
penetration is restricted even in the presence of inflammation (e.g., cerebrospinal
fluid),it suggests that extreme caution should be taken in the use of the agent.

“Resistant” – Implies that treatment with the antimicrobial agent is likely to fail.

“Susceptible-dose dependent” – New category for antibacterial susceptible testing.

Category implies that susceptibility of an isolate is dependent on the dosing regimen
that is used in the patient SDD has been included within the intermediate category
definition for antimicrobial agents. SDD is more specific and it conveys clinicians
that a higher dose can be considered for isolates with MICs (or zones) that in this
interpretive category.

87
 Organisms tests as “susceptible” to that treatment, and success my still occur in
around 60% of cases when the organism test as “resistant” to the agent used. The
apparent 60% response rate to ineffective antimicrobials is said to reflect the natural
response to many bacterial infections in an immunologically normal host.

Antibiotic Titrations: The intrinsic activity of antimicrobial drugs in vitro is usually

expressed in terms of the minimum inhibitory concentration (MIC). These values are
derived by titration of the drug against a standard inoculums of a pure culture if an
isolated bacterial species in broth or on agar plates. The MIC is the lowest
concentration that prevents the development of visible growth after a period of
incubation that is usually 16 – 20 hours for most common pathogens.

MIC is the mainstay of modern pharmacodynamics principles on the best antibiotic

dosing schedules and is certainly the single most important measure of an antibiotic’s
activity.

Process of setting Epidemiological Cut-offs and Breakpoints

EUCAST takes a different approach to developing interpretive criteria for MICs and
disk diffusion results than does the CLSI. EUCAST first establishes epidemiological
agent (78). Once the wild-type population has been described and epidemiological
cut-offs been decided, the wild-type distributions are categorized as susceptible,
intermediate or resistant, using pharmacokinetic/ pharmacodynamics data and clinical
data. The clinical breakpoints guide therapy, while the epidemiological cut-off values
are valuable for sensitive and early detection of emerging resistance.

According to European Committee on Antimicrobial Susceptibility Testing

recommendation Carbapenems are compared according to the susceptible,
intermediate or resistant categories. This new approach allows comparing these
carbapenems in a `MIC score’ talking into account the differences in breakpoints
between drugs. MIC also helps to identify the profile of new drugs so that their
clinical value is determined.

Clinical situations where MIC determination is essential clinically:

 Endocarditis
 Meningitis
 Endopthalmitis
 Sepsis
 Osteomyelitis
 Immunosuppressed patients
 Prosthetic devices
 Patient no responding despite `S’

In addition to clinical indications MIC is essential for

 Colistin for Enterobacteriacae and Acinetobacter spp

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  Vancomycin and daptomycin for S.aureus
 Levofloxacin for B.cepacia
 Oxacillin disc < 20 mm for S.pneumoniae
 Penicillin/Ampicillin for VGS in sterile sites
 Ticarcillin/Clavulanic acid, Chloramphenicol, Ceftazidime for S.maltophila

2 B) Assess the pharmacodynamics support available-

E. Monitoring of serum antibiotic level by HPLC (high performance liquid

chromatography)
F. Monitoring antibiotic quality by HPLC (high performance liquid chromatography)

2 C) Assess the manpower support available:

 ID physician (dedicated)
 Fully functional HICC and designated infection control officer
 Stewardship nurses
 Clinical pharmacists
 24/7 reporting facility for culture and sensitivity by Dept. of Microbiology

2D) Assess the information technology support available-

 Hospital information system (HIS)- Fully functional HIS including Laboratory

information system will augment the stewardship program by many folds
 Computerized order-Entry and Decision support Systems

Step – 3 Set up AMS Team

Antimicrobial Stewardship team (AMS team) is a multidisciplinary committee who will be

involved in executing the interventions (both front and back end strategy as described later )
and evaluating the adherence to AMSP. The members of AMS team are –

 ID physician
 Stewardship nurses
 HICC – Infection Control Officer and nurses
 Clinical microbiologist
 Clinical pharmacist with expertise in infection
 Quality improvement/patient safety managers
 Pharmacy department

Leadership (Antibiotic steward)

An antibiotic steward is physician who is trained in infectious diseases and infection control
or a microbiologist with training in infection control and antibiotic stewardship. In hospitals
without an ID Physician or microbiologist, any clinican with special interest in infection
control and antibiotic stewardship can function as an antibiotic steward.

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  Antibiotic steward should be responsible for reviewing the antimicrobial
prescriptions and giving a second opinion especially on the higher-end antibiotic
usage.
 Availability of more than one antibiotic steward in any one hospital will proved
flexibility in providing round the clock support.

Step -4: Frame Antimicrobial policy

Every hospital should frame their own hospital antibiotic policy in the form of a ‘Handbook
of Antimicrobial Use’. The core chapters of the Hand book have been depicted in table-2.

Treatment regimens of common infections of major systems-

This is the main component of the hand book; the major departments involved in each system
should frame the antibiotic treatment regiments for 6the infectious diseases under that system

i) Reference to be flowed – Every antibiotic treatment regimen should be

supported by a reference which has to be quoted in the chapters against each
indication of antimicrobial use.
Some of the examples are given below.

a. Harrision,IDSA (Infectious disease Society of America ) – For

Medicine
b. Sabistob’s textbook of Surgery
c. Any other guideline/standard book for other dept
d. Local Antibiogram should also be taken into consideration .However;
guideline should not be made only based on local antibiogram pattern.
ii) Common consensus – after preparing the treatment regimen, the major
departments involved for each system should initiate discussion among them
to arrive at a common consensus.
a. Intra Unit discussion
b. Intra departmental discussion
c. Inter Departmental discussion
iii) The AMS team members should coordinate via mail, personal and subgroup
meetings with various departments to arrive at the common consensus.
iv) Every stakeholder’s opinion and consensus should be taken so that once the
Hand Book is implemented, maximum adherence can be obtained.

Figure – 4: Template for treatment regimens of common infections

c.Inter Departmental discussion

iii. The AMS team members should coordinate via mail, personal and subgroup meeting
with various departments to arrive at the common consensus.

Iv. Every stakeholder’s opinion and consensus should be taken so that once the Hand
book is implemented, maximum adherence can be obtained.

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 Table-3: Chapter distribution of Handbook of Antimicrobial Use of a hospital

Chapters Name of the Chapter Should contains

1. Title page Name of policy, date, version, review date, and
contact details for normal hours and out -of-hours
enquiries
2. Goal of AMSP
3. List of available Unrestricted, restricted (approval of a specialist is
antimicrobials required) or permitted ofr specific conditions
4. General Guidelines
5. AMR Surveillance data Resistant pattern of common pathogens Overall,
of last year ICU/Ward/OPD wise, specimen wise
6. Treatment regimens of common infections
Should contain five columns- Disease, agents, antibiotic regimen in adult and
children, comments/suggestions (See the template below in figure – 4)
Infection of major systems Major department Involved are -
I GI and Intra – abdominal Common/Surgery/Medicine/Medical
Infections and surgical Gastroenterology
Ii CVS Infections Medicine/Cardio/CTVS
Iii Skin and soft tissue Infections Common/Medicine/Surgery/
Dermatology
iv Bone and Joint Infections Common/Ortho
v Respiratory Infections Common/Medicine/TB chest
vi Genitourinary Infections Common/Medicine/Urology/
Nephrology/OBG/Dermatology (for
STI)
Vii CNS Infections Medicine /Neuromedicine/Neuro
surgery
Viii Ocular Infections Ophthamalogy
Ix Dental Infections Dental department
X Empiric antibiotic therapy for ALL ICUs
ICU
Xi Patients with fever Neutropenia Oncology,Medicine
Xii Fir management in NICU Neonatology,Pediatric surgery
Xiii Children column in each system Pediatrics
Xiv Surgical site infections Surgery and all surgical departments.
8 Frequently asked questions
(FAQs)

Figure – 4: Template for treatment regimens of common infections

GI and intra- abdominal indections

Disease Etiological agents Antibiotics in adults Antibiotics in Remarks/
children Alternative
antibiotics
Acute Viral No antibiotics Nil When blood jor
Gastroenterit Entero toxigenic and usually required. mucus appears in
is Enteropathogenic E.coli prompt rehydrativion stool, or if there is

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 Non-typhoidal essential . if evidence of cholera
salmonella diarrhea persists or invasive
beyond 2 daysor in diarrhea;
immuno suppressed antibiotics are
patients – indicated in
ciprofloxacin 500 children
mgbd*5 days
Cholera V.cholerae Cap. Doxycycline Ciprofloxacin Prompt rehydration
300 mg. Single dose single dose 30 essential ,antibiotic
(6 mg/kg. maximum mg/kg therapy is only
300 mg or Tab. maximum1 g adjunct to
Ciprofloxacin 1 gm Above 8 years, rehydration
single dose Doxycycline 5
mg/kg to be
preferred
Bacillary Shigella Tab .Cefixime 400 Tab. Cefixime If no response then
Dysentery mg od*5 days (10 switch to
(8mg/kg/day) or Tab mg/kg/day/)*7 cefoperazone
Ciprofloxacin 500 days. Continue sulbactum i.v (150
mg bd* 5 days feeding and mg/kg/day)
add zinc
supplementatio
n
Amoebic Entamaoeba histolytica Metronidazole 400 Metronidazole
dysentery mg tds for 10 days 30- 35
mg/kg/day in
three divided
doses for 10
days
 Source : Antimicrobial Stewardship pocket guide, SVIMS

Step-5: Implement AMS strategies

Frontend strategies:

I) Formulary Restrictions:

This involves determining the list of restricted antimicrobial agents and criteria for their use
combined with an approval system which is subject to regular audit and feedback to the
prescribers. Though sounds more attractive and appears to be the most ideal way to achieve
antimicrobial stewardship, but practically implementing formulary restrictions is not that
easy. It creates lot of confusion as it directly impacts the clinician’s freedom to choose
antimicrobials. More so availability of the concerned authority to give approval all the time
further complicates the problem especially in emergency situations. Hence, instead of
surveillance on the usage of all antibiotics, monitoring higher-end antibiotics is a more
practical and implementable strategy.

 Antimicrobials can be classified into restricted, semi-restricted and un-restricted

groups (table-4).
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 All antimicrobial prescriptions must be countersigned in duplicates by the consultants
or faculty in charge of the unit, not by post graduate students or residents.

 Pharmacy will keep one prescription for its record purpose and will hand over the
second prescription to the AMS team.

 The AMS team will review the antibiotic prescription and give a second opinion by
countersigning on it. Further continuation of the antimicrobial use will depend upon
the approval from AMS team.The duration to obtain the approval from AMS team can
vary depending upon the class of antimicrobials.

o Restricted antimicrobials: This group include third line antibiotics active against
gram-negative bacteria such as Colistin, carbapenems and Tigecycline where more
vigilant monitoring is needed. For these antimicrobials, pharmacy supply of >1 day
can be made mandatory to obtain prior approval by AMS team.

o Semi-restricted antimicrobials: This group include third and fourth generation

cephalosporins and second line antibiotics active against gram-positive bacteria such
as teicoplanin, vancomycin, daptomycin, Linezolid. For these antimicrobials,
pharmacy supplyof >3 days can be made mandatory to obtain prior approval by AMS
team.

o Unrestricted antimicrobial: This group include first & second generation

cephalosporins, Cotrimaxazole, Azithromycin, clarithromycin and Fluoroquinolones
where ales vigilant monitoring is needed. Pharmacy supply need not requires AMS
team approval. However, retrospective review of antimicrobial use will be done by
AMS team from time to time.

Table – 4 : Proposed formulary restriction

Restricted antimicrobial Semi- Restricted Unrestricted antimicrobials

antimicrobials
Colistin Teicoplanin First & second generation
Carbapenem Vancomycin cephalosporins
Tigecycline Daptomycin Co-trimoxazole
Linezolid Azithromycin
Third and fourth Clarithromycin
generation cephalosporins Fluoroquinolones
Pharmacy supply of Pharmacy supply of Pharmacy supply does not
>1days requires prior >3days requires prior requires AMS team
approval by AMS team approval by AMS team approval. However,
(for second opinion) (for second opinion) retrospective review of
Pharmacy supply in Pharmacy supply need a antimicrobial use will be
duplicate prior to prescription in duplicate done by AMS team form
dispensing. Pharmacy will prior to dispensing. time to time.
send the prescription for Pharmacy will send the
compulsory second prescription for
opinion from AMS team compulsory second
within 24 hours opinion from AMS team
within 72 hours

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2) Antibiotic cycling:

Antibiotic cycling or antibiotic rotation refers to the development of strategies utilizing the
scheduledrotation of antimicrobials in order to minimize the emergence of bacterial
resistance. Theoretically, during the periods when an antimicrobial is out of rotation (i.e. off
the cycle) and its use is minimal, there won’t be antibiotic pressure; as a result resistance to
that drug will decline. These programstypically target gram-negative resistance and are
generally limited to the ICU setting.

Poor compliance:

Antibiotic cycling is in principle the most restrictive of all approaches to antimicrobial

stewardship asit involves dictating the clinicians exactly which antimicrobials are to be used
in a given time period. Therefore researches done on antibiotic rotation reveals that
compliance with the cycling protocol isextremely low. There could be many reasons behind it
such as

 Physicians may ignore the protocol and prescribe off-cycle antimicrobials to their
patients

 Allergies or toxicity may preclude administration of the on-cycle drug

 The final regimen may be tailored to culture results.

Back end strategies:

Back end strategies include antimicrobial review methods and providing timely feedback.

Antimicrobial review methods:

Though difficult to perform, but it is the most effective strategy to implement AMSP. This is
done attwo stages. First, during the clinical rounds, an exhaustive and thorough intra unit
review of various aspects of antimicrobial use can be carried out. This should be further
reviewed (for a second opinion)during stewardship rounds which should be carried out by
AMS team members. The various aspects of antimicrobial use which can be reviewed are

 Indication for antibiotic and compliance with policy

 Appropriateness of the antibiotic choice, dose, route and duration

 Duplicative therapy [potential overlapping spectra]

 Review of directed therapy based on microscopy or PCR, biomarkers or other rapid

tests.

 Timely de-escalation or escalation based on culture and susceptibility report.

 Potential for conversion from IV to oral route.

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  Requirement for therapeutic drug monitoring

 Any antibiotic related adverse events

 Any potential drug interactions

 Drug allergy if any

 Requirement for renal adjustment

 Need for extended infusion

Back-end strategies, although more labour-intensive, are:

 More widely practice.

 More easily accepted by clinicians.

 Provide a higher opportunity for educating and training the health care professionals.

 They probably provide a more sustained impact of improving the overall quality of
antimicrobial prescribing [Chung et al 2013]

Step-6: Educate and train:

Similar to any other health care program, AMSP also needs continuous etraining,
motivationand assessment of the health care providers. Developing antimicrobial stewardship
1s a behavioural change within the person. Hence, adequate motivational education MUST to
bring in such change.

 Who should receive education in Hospitals-Every stake holder should be educated

on rational use of antimicrobials.

o Medical practitioners (physicians and surgeons), pharmacists and nurses should be

educated about AMSP.

o AMSP should be brought in as a part of undergraduate, internship and post graduate

curriculum.

o Educating patients and the general public is also important and it may indirectly
support hospital education efforts. The following aspects should be addressed.

 General hygiene

 Hazards of Antibiotic use without prescription

 Discouraging over the counter sale

 Content of education -Content should be adapted to each profession.

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 o Basic knowledge of infection management,

o Basic microbiology

o Importance of prudent prescribing in tackling AMR

o Best practices for prescribing to support safe and effective prescribing administration
and monitoring of antimicrobial therapy.

 Who should deliver the training- It is usually delivered by the AMSP team
members. However, the administrators should take part active role and address
the audience time to timeto increase the seriousness of the training.

 Evaluation process -Without assessment, no educational training can be effective.

Variousassessment tools can be used for the competency assessment of the trainee
time to time.

o Attendance forms

o Completion certificates

o Questionnaires

o Case scenario based test

EVALUATION OF ANTIMICROBIAL STEWARD PROGRAMME

Measurement of prescribing is essential to evaluate the impact of stewardship intervention on

clinical practice and demonstrate benefits for patients. It is said that “If you cannot measure
it, you cannot improve it”. There are various ways the impact of AMSP is evaluated (table 5).

Table 5 – Methods for evaluation of AMSP

1.Policy adherence indicator (process indicator)

 Antimicrobial Stewardship Audit
2.Antibiotic Usage-outcome indicator
 Antibiotic usage surveillance (DDDs and DOTs)
3.Antimicrobial resistance –outcome indicator
 AMR surveillance – Manual and WHONET
4.Clinical outcome indicators-
 Morbidity and mortality
5.Financial outcome indicators

Policy Adherence outcome indicators

Antimicrobial Stewardship Audits:-

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Antimicrobial stewardship audits (ward rounds) should be done to monitor the adherence to
antibioticpolicy of the hospital. The members of AMS team members should carry out this
audit. Antibiotics Prescription Card should be implemented in the hospital (figure-5). For
each patient on antibiotics, this card should be filled and countersigned by the ICU or ward
liaison. During the AMS audit rounds, the AMS team will evaluate the correctness filling the
card.

The policy adherence outcome indicators include-

a) Antimicrobial prescription card filling adherence rate = No. of cards filled / Total no. of
antimicrobial prescriptions given in the same period X 100

(b) De-escalation adherence rate = No. of times de-escalation done after the culture
sensitivity report! No. of possible de-escalations indicated in the same period X 100

(c) Handbook adherence rate = No. of times antimicrobials prescribed according to

antimicrobial stewardship pocket guide, SVIMS/ Total no. of antimicrobial prescriptions
given in the same period X 100

(d) Percentage of culture sent before administration of antimicrobials = No. of times

bloodculture sent before administration of antimicrobials / Total no. of blood culture sent in
the same period X 100

(e) Timely cessation of antibiotics given for surgical prophylaxis.

Antimicrobial usage outcome indicators

This will be calculated based on DDD (Defined Daily Dose) and Days of Therapy (DOT).

(a) No of Defined Daily Dose (DDD)-

Defined Daily Dose (DDD) is the average maintenance dose per day for a drug used for
its main indication in adults.

Therapeutic dose should not be used for calculating antibiotic usage because it varies
between the persons depending upon the weight, disease, associated factors such as renal
adjustment etc. Hence, DDD is the best indicator to calculate the antimicrobial
consumption. Every antimicrobial has a WHO assigned DDD WHOCC- ATC/DDD
Index which should be used for calculating the DDDS (table 6).

No of DDDs = Therapeutic dose (No. of Tablets used X gm per tablet) / WHO defined
DDD of the antimicrobial.

DDDs per 100 patient days: No of DDDs used in an ICU in a period/ Total patient days
of the ICU in the same period (sum of occupied beds daily)X 100

Table-6: Antibiotics, their therapeutic dose and Defined daily dose (DDD)

ATC Antibiotics Antibiotic Therapeutic DDD

Index Name dose

97
 J01C Beta- lactam antibacterials (Pn)
J01CE01 Crystalline 2 lakh units 3.6g
(Benzyl) QDS
Penicillin
J01CR05 Piperacillin 4.5 gm QDS 14g
plus
Tazobactam
J01D Other Beta- lactam antibacterials
J01DH02 Meropenem 1 gm TDS 2g
J01DC 2nd generation cephalosporin
J01DC02 Cefuroxime 0.5g(o)3g(p)
J01DD 3 rd generation cephalosporin
J01DD04 Ceftriaxone 1 gm BD 2g
J01DD12 Cefaperazone 2gm BD 4g
Sulbactum
J01DD08 Cefixime 1 gm BD 0.4 g
J01DD02 Ceftazidime 1 gm TDS 4g
J01DD01 Cefotaxime 1 gm BD 4g
J01FA Macrolide and Lincosamides
J01F Azithromycin 250 mg OD 0.3 g
S01AA26 Amino glycoside
J01G Amikacin 750 mg OD 1g
J01GB03 Gentamicin 0.24g
J01MA Fluoroquinolones
J01MA02 Ciprofloxacin 200 mg BD 1 g(o) 0.5 g
(p)
J01MA12 Levofloxacin 750 mg OD 0.5 g
J01MA14 Moxifloxacin 400 mg OD 0.4g
J01MA01 Ofloxacin 400 mg BD 0.4 g
Others
J01XB01 Colistin 2 million units 3 MU
TDS
J01XA01 Vancomycin 2 gm BD 2g
G01AF01 Metronidazole 0.5g TDS 0.5g

(b) Days of Therapy (DOT per 100 patient days)-

Days of Therapy (DOT) per 100 patient days-

Total days of therapy of an antimicrobial in an ICU in a period/ total patient days of the ICU
in the same period (sum of occupied beds daily)*100

Antimicrobial resistance outcome indicator

AMR Surveillance is the key to generate local antibiogram pattern of the hospital which can
be used to monitor the trend of AMR. Department of microbiology should carry out the
surveillance to generate data on AMR and communicate the clinicians time to time.

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AMR can be generated at various levels

a. Location wise AMR pattern (ward/ICU/OPD wise)

b. Specimen wise AMR pattern

c. Overall AMR pattern of the hospital. .

There are two methods by which AMR Surveillance is carried out.

a. Manual data entry and analysis by using Microsoft excel.

b. WHONET

Clinical outcome indicators

These include the parameters to measure the infection related morbidity and mortality.

a. Morbidity indicators.-

i. Length of stay in ICU

ii. Surgical site infection (SSI) rate

iii. Rate of occurrence of complication due to sepsis e.g. organ failure

iv. Rate of occurrence of readmission within 30 days

v. Ward to ICU transfer rate

vi. Antibiotic-related toxicity (e.g. amino glycoside) rate

vii. Rate of CD1 (C. difficile infection)

b. Mortality indicator-

1. Death due to sepsis by sepsis score

2. Standardized Mortality Rates (SMRs)

Financial outcome indicators-

a. Antibiotic cost per patient day-Antibiotics used per day in an ICU X cost of the
antibiotics

b. Antibiotic cost per year-Antibiotics used in an ICU for the whole year X cost of the
antibiotics

c. Antibiotic cost per admission-Antibiotics used in the ICU in a given period X cost of the
antibiotics / no. of admissions in the same ICU during the period X 100.

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References:

1. Dennis L K, Anthony S F, J L, Joseph Loscalzo C. Harrison's Principles of Internal Medicine.

19th ed. United States: McGraw Hill Professional; 2015.

2. Bennett J, Dolin R, Blaser M. Mandell, Douglas, and Bennett's Principles and Practice of
Infectious Diseases. lst ed. Philadelphia, PA: Elsevier; 2015.

3. Brink A, Messina A, Feldman C, Richards G, Becker P, Goff D et al. Antimicrobial

stewardship across 47 South African hospitals: an implementation study. The Lancet
1nfeetious Diseases. 2016;16(9)21017t 1025.

4. Chandy S, Naik G, Charles R, Jeyaseelan V, Naumova E, Thomas K et al. The Impact of

Policy Guidelines on Hospital Antibiotic Use over a Decade: A Segmented Time Series
Analysis. PLoS ONE. 2014;9(3):e92206.

5. Charani E, Castro-Sanchez E, Sevdalis N, Kyratsis Y, Drumright L, Shah N et al.

Understanding the Determinants of Antimicrobial Prescribing Within Hospitals: The Role of
"Prescribing Etiquette". Clinical Infectious Diseases. 2013;57(2):188-196.

6. Charani E, Edwards R, Sevdalis N, Alexandrou B, Sibley E, Mullett D et al. Behavior Change

Strategies to Influence Antimicrobial Prescribing in Acute Care: A Systematic Review.
Clinical Infectious Diseases. 2011;53(7):651-662.

7. Goff D, Bauer K, Reed E, Stevenson K, Taylor J, West J. Is the “Low-Hanging Fruit" Worth
Picking for Antimicrobial Stewardship Programs?. Clinical Infectious Diseases.
2012;55(4):587-592.

8. Leber A, Everhart K, Balada-Llasat J, Cullison J, Daly J, I-Iolt S et a1. Multicenter

Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria,
Viruses, and Yeast in Cerebrospinal Fluid Specimens. Journal of Clinical Microbiology.
2016;54(9):2251-2261.

9. Team C. "Chennai Declaration": 5-year plan to tackle the challenge of anti-microbial

resistance. Indian Journal of Medical Microbiology. 2014;32(3):221.

ANTIMICROBIAL RESISTANCE (AMR) SURVEILLANCE (MANUAL &

WHONET)

INTRODUCTION

Antimicrobial resistance (AMR) is a microorganism's ability to resist the action of one or

more antimicrobial agents. The consequences can be severe, as prompt treatment with
appropriate antimicrobial agents is the single most effective intervention to reduce the risk of
a poor outcome from serious infections. Development of AMR is a natural phenomenon
caused by mutations in bacterial genes, and many of the genetic elements coding for AMR
can spread between bacteria. The major drivers behind the occurrence and spread of AMR

100
are the overuse/ misuse of antimicrobial agents and the transmission of antimicrobial-
resistant microorganisms between humans, between animals, and between humans, animals
and the environment. While antimicrobial use exerts ecological pressure on bacteria and
contributes to emergence and selection of AMR, poor infection prevention and control
practices and inadequate sanitary conditions favour the further spread of these bacteria.

AMR surveillance is the cornerstone for assessing the burden of antimicrobial resistance and
for providing the necessary information for action in support of local, national and global
strategies.

GLOBAL AMR SURVEILLANCE

The Global Antimicrobial Resistance Surveillance System (GLASS) has been launched
in May 2015 by WHO to support a standardized approach for AMR data collection, analysis
and sharing at a global level, in order to inform decision-making, drive local, national and
regional action and provide the evidence base for action and advocacy. GLASS aims to
combine clinical, laboratory and epidemiological data on pathogens that pose the greatest
threats to health globally.

NATIONAL AMR SURVEILLANCE

1)ICMR AMR Surveillance

In India, to streamline data collection and to have nation-wide picture, the Indian Council
ofMedical Research (ICMR) in 2013 set up an AMR surveillance network. Data are being
collected from four tertiary care hospitals across the country through its six nodal centers on
six pathogenic groups covering 90% of the WHO priority pathogens:

(i) Diarrhoeagenic bacterial organisms: CMC, Vellore

(ii) Enteric fever pathogens: AIMS, New Delhi
(iii) Enterobacteriaceae causing sepsis: PGIMER, Chandigarh
(iv) Gram-negative non-fermenters: CMC, Vellore
(v) Gram positives including MRSA: JIPMER, Puducherry
(vi) Fungal infections: PGIMER, Chandigarh.
The aim of establishing this ICMR network is,

1) To collect a nationally representative data on drug resistance and monitor trends across
the country
2) To generate evidence on mechanisms of resistance in different pathogenic groups
3) To guide antimicrobial policies for both treatment and prophylaxis
4) To direct hospital infection control efforts that facilitates prevention of the spread of
resistant organisms.
Work profile of ICMR nodal centers

101
 The ICMR published standard operating procedures (SOP) for bacteriology and
mycology to create uniformity and harmonization of the clinical microbiology processes
and procedures across the centers to overcome methodological limitations.
 The uniqueness of ICMR network lies in creating a comprehensive data including the
mechanisms of resistance and research studies which enables the understanding of
transmission dynamics, clonality and forecasting AMR trends and patterns over the
period through molecular studies.
 The biggest challenge of this network is that the data collected through this network are
from tertiary care hospitals and do not reflect the AMR patterns in the community.
 AMR surveillance data give indication of overall increase or decrease in resistance levels
but do not provide sufficient information to guide practice at a local level.
Guidelines for hospital antibiogram followed by ICMR:

ICMR has adopted a standard hospital antibiogram guideline which is a periodic summary of
antimicrobial susceptibilities of local bacterial isolates submitted to the hospital's clinical
microbiology laboratory and are often used by clinicians to assess local susceptibility rates, as
an aid in selecting empiric antibiotic therapy, and in monitoring resistance trends over time
within and across institutions.

 The data should be analyzed annually. Or if the number of isolates are more, this can be
done six monthly or even more frequently.
 At least 30 isolates should be present for inclusion in the analysis
 The isolates that are obtained from diagnostic testing should only be included and those
from surveillance cultures (MRSA screening) or colonizers should not be included
 Include results for the antibiotics that are routinely tested
 Only the first isolate from a patient irrespective of the specimen site should be included
 The cumulative antibiogram should present only the percentage susceptible and not those
which are intermediate susceptible
 Stratify the antibiogram into outpatient, inpatient and ICU data
2)National Programme For Containment Of Antimicrobial Resistance

In parallel to ICMR AMR surveillance network, there is another national AMR surveillance
program is ongoing titled 'National Programme for Containment of Antimicrobial Resistance'
funded by NCDC. It covers more than 13 nodal centres including JIPMER.

METHODS OF PERFORMING AMR SURVEILLANCE

AMR Surveillance is conducted in two ways. 1) Manual AMR Surveillance and 2)

WHONET

Manual AMR Surveillance

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This is the most common way of conducting AMR surveillance. Here, the hospital
antibiogram is entered on excel sheet on daily basis manually. After a defined period of time
(e.g. quarterly or yearly), the data analysis is carried out manually. The major limitation of
manual AMR surveillance is the error prone and labour intensive nature of manual data
analysis. Various parameters analyzed in AMR surveillance are:

 Specimen wise AMR analysis

 Location wise AMR analysis (overall ICU, ward or OPD)
 Unit specific AMR analysis (specific ICU)
 Differentiating HAI and CAI
 Overall isolation rate
 Detection of MDR, XDR and PDR
Table: Definitions of MDR, XDR and PDR

MDR Multidrug resistant non-susceptible to >1 agent in > 3 antimicrobial categories

XDR Extended drug resistant non-susceptible to >1 agent in all but < 2 categories.

PDR Pan drug resistant non-susceptible to all antimicrobial agents listed.

WHONET

WHONET is a free software developed by the WHO Collaborating Centre for Surveillance of
Antimicrobial Resistance for laboratory-based surveillance of infectious diseases and
antimicrobial resistance. The principal goals of the software are:

 to enhance local use of laboratory data; and

 to promote national and international collaboration through the exchange of data.
WHONET can be used by individual laboratories or as part of a national and international
surveillance network. At present, the software, available in 17 languages, is used in over 80
countries around the world managing data from over 1000 clinical, public health, veterinary,
and food laboratories.

What can WHONET do?

WHONET has three main components,

 Laboratory configuration- WHONET permits the customization of the software for use in
your institution. You can indicate which antimicrobials you test in the laboratory, patient
care areas served, data fields that you want to include in the surveillance program, and
microbiological alerts of unusual or important organisms and resistance phenotypes.
 Data entry and clinical reporting-WHONET allows the routine entry of susceptibility test
results as well as the retrieval, correction and printing of clinical records. During data

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 entry, WHONET can provide immediate feedback to technicians on important strain
phenotypes.
 Data analysis- WHONET has a user-friendly interface permitting many types of analysis.
Options include isolate line-listings and summaries, such as organism frequencies over
time, antimicrobial susceptibility test statistics, zone diameter and MIC histograms,
antibiotic scatter plots and regression curves, and antibiotic resistance profile line-listings
and summaries. WHONET also has a number of alert features which permit the detection
of unlikely or important results as well as possible hospital or community outbreaks of
bacterial or non-bacterial species.
What is BacLink?

This software is useful for those laboratories in the world already have computer systems
(laboratory information system) for managing microbiological data.

Examples include:

The purpose of the BacLink software is to facilitate the conversion of data from your
computer system into WHONET. You could do this interactively on a weekly, monthly, or ad
hoc basis. BacLink is available free-of-charge from the World Health Organization as part of
the WHONET package.

By using BacLink, you can thus avoid the manual entry of results into WHONET. A related
benefit in the context of multi-center collaborations is the standardization of data from a
number of incompatible data sources into one common structure that can be analyzed with
WHONET. The aim of this workshop is to familiarize the participants on the use of
WHONET and BacLink including data entry, laboratory configuration and data analyses.

References:

1) Global Antimicrobial Resistance Surveillance System (GLASS) manual. WHO

2) Walia K, Ohri VC. Strengthening surveillance key to addressing antimicrobial resistance.
Indian J Med Microbiol 2016;34:413-5.
3) S Joshi. Hospital antibiogram: A necessity. Indian J Med Microbiol 2010; 28(4): 277-80.
4) European Centre for Disease Prevention and Control. Antimicrobial resistance
surveillance in Europe 2014. Annual Report of the European Antimicrobial Resistance
Surveillance Network (EARS-Net). Stockholm: ECDC; 2015
5) Stelling JM, O'brien TF. Surveillance of antimicrobial resistance: the WHONET
program. Clinical infectious diseases. 1997 Jan 1 ;24(Supplement l):S157-68.
6) WHONET: http://www.whonet.org
7) Magiorakos AP et al. Multidrug-resistant, extensively drug-resistant and pandrug-
resistant bacteria: an international expert proposal for interim standard definitions for
acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.111 l/j.1469-
0691.2011.03570.x. PubMed PMID: 21793988.

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