APPENDIX: 1(Research /Study -Synopsis Summary)

Name and

address of

Applicant:

Mobile No:

DR. CHILUVERY BHAKTI RAMESH

‘UTKARSH’ , plot no.1035,25/6th floor , J. A. Rahul Marg ,

Prabhadevi , Mumbai – 400025.

09850189579

Designation: Junior Resident- I Departmen

t:

MICROBIOLOGY

Title of research /

dissertation

protocol

“BACTERIOLOGICAL PROFILE AND ANTIMICROBIAL

SUSCEPTIBILITY PATTERNS OF BLOOD CULTURE

ISOLATES AMONG ICU PATIENTS IN A TERTIARY CARE

HOSPITAL”

is this research for your dissertation..?write: YES / NO YES

:For office use only:Research Protocol Application No:

Remark of PG

Education Co-

ordination

Committee

(PGECC) /

Scientific

committee

Approved / Not Approved

Signature of

PGECC with date

Remark of

1

Institutional Ethics

Committee (IEC)

Approved / Not Approved

Signature of

Member Secretory-

IEC with date

All the following details to be filled by applicant:-

1. Title of the study-protocol: “BACTERIOLOGICAL PROFILE AND

ANTIMICROBIAL SUSCEPTIBILITY PATTERNS

OF BLOOD CULTURE ISOLATES AMONG ICU

PATIENTS IN A TERTIARY CARE HOSPITAL”

2. is this research for your

dissertation..? (YES/NO)

YES

3. Name, Designation &

Postal-Address with

Mobile number,

e-mail of:UG/PG-student /

Investigator /Research

worker

DR. CHILUVERY BHAKTI RAMESH

Junior Resident – I

Resident Doctors Quarters,

Civil Hospital Campus, Solapur – 413003.

09850189579

chiluverybhakti@gmail.com

4. Name, Designation &

Postal-Address with

Mobile number,

e-mail of:UG/PG-Guide /

Co-Investigator / Co-

Research worker

DR. INGOLE KISHOR V.

Professor & Head of Department

Dept. of Microbiology

Dr. V.M. Govt. Medical College & Civil Hospital,

Solapur – 413003.

Mobile No- 09850267140

2

kishorvi@yahoo.com

5. For PG Student Only (To be written on IEC approval certificate)

Full Name of PG-Student

(Capital; Start With

Surname)

DR. CHILUVERY BHAKTI RAMESH

Name of Department Department of Microbiology

Candidate admitted year 2017

Course (MD or MS) &

Subject

M.D.Microbiology

College Name & Address Dr. Vaishampayan Memorial Government Medical

College Solapur. Opp. District Court, Solapur–

413003.

11. Is this research

sponsored (Funded) by

private agency?

If yes, give details of

authentic sponsorer like

Name, Designation &

Address with

Telephone,Fax, e-mail,

website, etc. And mention

Protocol number / version

No.

12. For sponsored (Funded)

research by private/govt-

agency/institute;

3

1. Give all details of

financial budget of the

research project.

2. DCGI-approval, Patients

insurance, tripartite

agreement, IEC-

approval of other

institutes, protocol with

all details, investigators’

brochure, investigators

CV etc

3. Any other relevant

documents as per

regulatory govt.

agencies current

guidelines.

-

13. Justification / rational for

the study / study

background

Bloodstream infection (BSI) is one of the

most important causes of morbidity and mortality

globally.1 Especially in hospitalized patients it is a

common and deadly problem.2 It is also a leading

infectious complication among critically ill patients.

It represents about 15% of all nosocomial

infections.3

For the treatment, the isolation of bacterium

from blood is valuable, but there is also urgent

need of antimicrobial therapy, so sample is taken

and treatment is started and after blood culture

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result, patient is treated as redirected by in vitro

antibiotic sensitivity test.8,9

Septicaemia is a clinical term used to

describe severe life-threatening bacteremia in

which multiplying bacteria release toxins into the

blood stream and trigger the production of

cytokines, causing fever, chills, toxicity, tissue

anoxia, reduced blood pressure and collapse.

Septic shock is usually a complication of

septicemia with Gram-negative bacilli, and less

frequently, Gram-positive organisms and prompt

treatment is essential.5

Continuous septicemia occurs primarily in

patients with intravascular infections like

endocarditis, septic thrombophlebitis, infections

associated with intravascular catheter, septic

shock whereas intermittent septicemia occurs in

patients with localized infections like lung, urinary

tract, soft tissues infections.6

Bloodstream infections are potentially life-

threatening and require rapid identification and

antibiotic susceptibility testing of the causative

pathogen. Both Gram positive and Gram negative

bacteria causes bacteremia and septicemia. Gram

negative septicemia, also known as endotoxic

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shock, which is more severe than Gram positive

septicemia.7

The impact of BSI on patient outcome is

tremendous. It increases the mortality rate,

prolongs patient stay in an intensive care unit/

hospital and generates substantial extra costs.3

Detection of bacteremia by rapid and

reliable method is by culturing blood. The blood

should be collected aseptically before the

administration of antibiotics.4

If the infection is caused by multidrug

resistant (MDR) bacteria morbidity and mortality

will increase which leads to great economic loss

encompassing use of more expensive antibiotics to

treat infection as well as threat of resistance to

them. The infections caused by MDR organisms

are more likely to prolong the hospital stay,

increase the risk of death and require treatment

with more expensive antibiotics.10

The surveillance of blood stream pathogens

in a hospital is important in monitoring the

spectrum of microorganisms that invade blood

stream and types of organisms associated with

particular clinical discipline. Such data are often

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used to determine empiric antibiotic therapy and to

alert clinicians to emerging pathogens that may

pose a threat to community.11 As there is high

mortality and morbidity associated with

septicaemia a right choice of empiric therapy is of

utmost importance. Rapid detection and

identification of clinically relevant microorganisms

in blood culture is very essential and determination

of antimicrobial susceptibility pattern for rapid

administration of antimicrobial therapy has been

shown to reduce mortality and morbidity

associated with blood stream infections.12

Hence the aim of this study was to identify

the bacterial blood culture isolates and their

antimicrobial susceptibility patterns of these

isolates among ICU patients suspected for

septicemia in tertiary care center.

This study provides current information on

the prevalence of bacteria that cause septicemia

among children. Most importantly this study

indicates the current picture of antimicrobial

resistance patterns on bacterial isolates from

blood. This will help clinicians provide safe and

effective empirical therapies, develop rational

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prescription programs and make policy decisions

and finally assess the effectiveness of all.

14. Aim and Objectives: Aim :

To identify the bacterial blood culture

isolates and their antimicrobial susceptibility

patterns of these isolates among ICU patients

suspected for septicemia in tertiary care center.

Objectives :

1. To know the occurrence of blood stream

infection.

2. To isolate and identify the bacterial agent from

the blood sample.

3. To determine the antibiotic susceptibility

patterns of the isolates.

15. Research Study design A prospective study.

16. Research study Centre ICU, TICU, NICU, PICU of

Shri.ChattrapatiShivajiMaharajSarvopcharRugnala

y,Solapur.

17. Research Study

population source

Patients admitted in Intensive Care Unit (MICU,

TICU, NICU and PICU) fulfilling the inclusion

criteria will be enrolled in study.

18. Research Study Sample

size

(No of patients/subjects for

Sample size for the study is 370.

8

study):

19. Mention Proposed

method for study subject

recruitment/enrollment.

A prospective study.

20. Probable Duration for the

study completion

2 years.

21. Methodology in brief BLOOD SAMPLE COLLECTION

Blood samples were collected from patients

with suspected BSIs, preferably before

administration of antimicrobial therapy. 5 ml blood

sample from each adult, 2-5ml from each child and

0.5-2ml from infant’s and neonates was collected

aseptically using 70% alcohol and 2% tincture of

iodine from a peripheral vein under strict aseptic

precautions and inoculated immediately into 50ml

Brain Heart Infusion (BHI) Broth with 0.025% of

sodium polyanetholsulphonate as anticoagulant. In

pediatrics cases, 1-2ml of blood was inoculated in

5-10ml of BHI broth.[13] The samples were

collected in blood culture bottles containing Brain

Heart infusion broth making a dilution of 1 in 10 to

nullify the natural bacteriostatic/bacteriocidal

activity of blood and immediately transported to the

laboratory for further processing.

CULTURE

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The inoculated blood culture bottles were

incubated overnight at 37ºC aerobically and the

first subculture was done after 18-24 hours of

incubation, the second on third day and final

subculture was done on seventh day. Subcultures

were done on Blood agar, MacConkey agar and

selective media if required as per the clinical

diagnosis.

The specific identification of bacterial

pathogen was done based on cultural colony

characteristics, Gram's staining and biochemical

test as per standard bacteriological techniques.[13]

ANTIBIOTIC SENSITIVITY TESTING

The antibiotic susceptibility testing of the isolates were

done by Kirby- Bauer disk diffusion method on Mueller

Hinton agar. Isolates were grown in peptone water by

incubating at 37º C and turbidity was matched with 0.5

MacFarland standards. Then lawn culture was done

on Mueller Hinton agar plate and commercial

antibiotic disks were placed. The plates were

incubated at 37º C overnight and on the next day the

zones of inhibition were measured and susceptibility/

resistance interpreted according to CLSI guidelines

2017.[14] A provisional report was issued after every

subculture, and if after 7 days no growth was obtained

10

the sample was reported as negative as follows.

PARAMETERS :

Samples (Blood collected aseptically from ICU,

TICU , NICU , PICU)

Overnight Incubation for 18 – 24 hours.

Inoculation on Blood agar and Mac Conkey agar.

Culture Colony characteristic.

Gram staining.

Standard biochemical tests.

Isolate identified.

Antibiotic susceptibility pattern assessment.

22. Inclusion criteria 1. Patients admitted in Intensive Care Unit (ICU,

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NICU, PICU, TICU) of a tertiary care hospital.

2. Blood samples of clinically suspected

Septicaemia

23. Exclusion criteria 1. Samples other than above fore said.

2. Patient admitted with :

- Snake Bite.

- Poisoning cases.

- Suicidal / Homicidal cases.

24. Details of new

investigational product

(eg Drugs/surgicals, etc)

if any:

(Name, dose, route of

administration, frequency

of administration, efficacy

& safety parameters,

procedure, etc)

-

25. Whether Case record

form (CRF)/Data

Collection form attached

to protocol..?

YES, attached.

26. Do you need exemption

from obtaining Informed

Consent form (ICF) from

study subjects?

No.

12

if yes give justification

27. Have you included

format/ proforma in your

protocol for patient

information sheet (PIS) &

Informed Consent Form

(ICF) in local

language/patients

language as per

Schedule-Y of THE

DRUGS AND

COSMETICSRULES,

1945

1. PIS & ICF- Marathi: yes or No YES

2. PIS & ICF- Hindi: yes or No YES

3. PIS & ICF- English: yes or No YES

4. any other language

23. Statistical analysis Appropriate Statistical analysis will be done using

SPSS/ Gpi into Statistical progressives wherever

applicable.

24. Are there Any Likely

Adverse effects /

complications related to

this clinical study if any?

and mention measures

for its management.

No.

25. Give details of : Proposed

compensation &

reimbursement of

incidental expenses and

13

management of research

related and unrelated

injury / illness during and

after research period.

-

26. Is there any financial

burden to the patient due

to this research project..?

eg investigation,

medications, surgicals,

etc

No.

27. Criteria for protocol

violation.

No.

28. Study subjects drop-out

criteria

Contamination during sample collection /

Laboratory contamination.

29. REVIEW OF RESEARCH WORK PROGRESS

Reviews 1st quarter 2nd quarter 3rd quarter Final quarter

Review of

progress of

project

December

2017

To

April 2018

May2018 To

September

2018

October

2018 To

Feb 2019

March 2019

To

July 2019

Review of

collection of data

April 2018 September

2018

February

2019

July 2019

Review of

analyzed data

July 2019 August 2019 October

2019

November

2019.

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30. Write name of persons

responsible for Privacy,

Confidentiality, Archival of

data (data / record

keeping)..?

DR. CHILUVERY BHAKTI RAMESH

31. Who is/are Authorized for

publication of data?

DR. INGOLE KISHOR V.

DR. CHILUVERY BHAKTI RAMESH

32. Mention any conflicts of

interests if any…

(www.icmr.nic.in/

guidelines.htm)

No conflicts of interests.

33. What are likely Ethical

issues involved in the

study?

No ethical issue involved in this study.

34. Whether

Investigator/UG/PG-

Guide / Research worker

is member of Ethics

Committee.?

if yes mention name

No.

35. If involvement of other Dept; then mention-

Name of that dept,sign, name&stamp of

Head Of that Dept for permission of research work in that dept.

1) Head of department :- Dr. H. B. Prasad.(Medicine)Dr. V. M. Govt. Medical College, Solapur

15

2) Head of department :- Dr. A . V .Varudkar.(Surgery)Dr. V. M. Govt. Medical College, Solapur

3) Head of department :- Dr. D. V. Kurdukar.(Obstetrics &Gynaecology)Dr. V. M. Govt. Medical College, Solapur

4) Head of department :- Dr. Mrs. S.V. Savaskar(Pediatrics)Dr. V. M. Govt. Medical College, Solapur

36. Date

37. We, the undersigned, have read, discussed, understood and modified

accordingly the protocol for the research study entitled above and hereby agree to

conduct the research work in accordance with protocol and to comply with all

requirements of ICMR & CDSCO guidelines

(http://icmr.nic.in/ethical_guidelines.pdf&http://www.cdsco.nic.in/html/GCP1.html).

Further, it is stated that to the best of my knowledge there is no ethical

dispute in this research protocol and therefore may be approved by the

Institutional Ethics Committee, Dr VM Govt. Medical College Solapur.

Also:

i. I have reviewed the clinical protocol and agree that it contains all

the necessary information to conduct the study. I will not begin

the study until all necessary Ethics Committee and regulatory

approvals have been obtained.

ii. I agree, to conduct the study in accordance with the current

16

protocol. I will not implement any deviation from or changes of

the protocol without agreement by the Sponsor (if any) and prior

review and documented approval/favorable opinion from the

Ethics Committee of the amendment, except where necessary to

eliminate an immediate hazard(s) to the trial Subjects or when the

change(s) involved are only logistical or administrative in nature.

iii. I agree to conduct and/or supervise this research work at my site

personally and/or under supervision of expert in that subject.

iv. I will ensure that the requirements relating to obtaining informed

consent and ethics committee review and approval specified in

the GCP guidelines are met.

v. I agree to ensure that all associates, colleagues and employees

assisting in the conduct of the study are suitably qualified and

experienced and they have been informed about their obligations

in meeting their commitments in the trial.

vi. I agree to maintain adequate and accurate records and to make

those records available for audit/inspection by the Sponsor, Ethics

Committee, Licensing Authority or their authorized representatives,

in accordance with regulatory and GCP provisions; I will fully

cooperate with any study related audit conducted by regulatory

officials or authorized representatives of the Sponsor.

vii. I agree to promptly report to the Ethics Committee all changes in

the research work activities and all unanticipated problems

involving risks to human subjects or others.

viii. I agree to inform immediately within 24 hour, all unexpected

17

serious and non serious adverse events to the Ethics Committee

and/or to Sponsor as well as.

ix. I will maintain confidentiality of the identification of all participating

study patients and assure security and confidentiality and archival

of study data.

x. I agree to comply with all other requirements, guidelines and

statutory obligations as applicable to clinical investigators

participating in this research work.

xi. I will inform the IEC of study completion final report,

discontinuation, closure, termination of the research work.

xii. Also all the information given above from point no 01 to 37 are

true.

38. Signature with name:

-UG/PG-Student /

Investigator /

Research worker

DR. CHILUVERY BHAKTI RAMESH

39. Date:

40. Signature & Stamp

with name of

-UG/PG-Guide /

Co-Investigator /

Co-Research Worker

DR. INGOLE KISHOR V.

41. Date:

42. Signature & Stamp

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with name of

-Prof & Head

of the Department DR. INGOLE KISHOR V.

43. Date

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