| CTRI Number |
CTRI/2026/03/105773 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate how Antibiotics Are Started and Fine-Tuned in ICU Infections |
|
Scientific Title of Study
|
A Prospective Observational Study on Antibiotic De-escalation Practices and Outcomes in ICU Patients with Suspected or Confirmed Infections |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4906_Version 2.0 dated 26.10.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Kothekar |
| Designation |
Professor |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, ACTREC, Tata Memorial Centre, Kharghar, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9769633568 |
| Fax |
|
| Email |
amolkothekar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Kothekar |
| Designation |
Professor |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, ACTREC, Tata Memorial Centre, Kharghar, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9769633568 |
| Fax |
|
| Email |
amolkothekar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajai John Mathew |
| Designation |
Senior Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
1116, Haffkine doctors quarters, GD Ambedkar marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09562414070 |
| Fax |
|
| Email |
ajaymat@icloud.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai - 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr. E Borges Road, Parel, Mumbai - 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amol Kothekar |
Tata Memorial Centre |
Department of Anesthesia Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Centre, Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA |
9769633568
amolkothekar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital IEC I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults more than 18 years admitted to ICU
2. Broad spectrum antibiotic use in first 48 hours of ICU admission
3. Expected ICU stay more than or equal to 48 hours.
|
|
| ExclusionCriteria |
| Details |
Advanced malignancy with Best supportive care |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of (Antibiotic de-escalation) ADE within the cohort |
Day 2 to day 28 of starting antibiotic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Rate of early discontinuation of all antimicrobial therapy within the cohort
2. Duration of antibiotic therapy
3. Incidence of de-escalation in different infection types
4. Reason for no De-escalation
5. ICU and hospital length of stay (LOS).
6. ICU mortality.
7. Positive test for C. difficile within 28 days of initial antimicrobial
|
Day 2 to day 28 of starting antibiotic |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective observational study evaluates antibiotic de-escalation practices and associated outcomes in adult ICU patients with suspected or confirmed infections receiving broad spectrum antibiotics. Conducted in the medical and surgical ICUs of Tata Memorial Hospital and ACTREC, the study includes adults admitted to ICU for more than 48 hours who receive broad-spectrum antibiotics within the first 48 hours of admission. ADE is defined as narrowing antibiotic spectrum, stopping combination agents, or discontinuing empiric coverage for non-isolated pathogens. The primary outcome is the rate of ADE, while secondary outcomes include early discontinuation of antibiotics, duration of therapy, factors influencing ADE decisions, ICU and hospital length of stay, mortality, and incidence of Clostridium difficile infection. Patients are followed until ICU discharge or death, with data collected on demographics, severity scores, microbiology, and antibiotic use. The study aims to generate real-world evidence on ADE frequency, safety, and clinical impact in ICU settings, supporting antimicrobial stewardship efforts
|