| CTRI Number |
CTRI/2025/07/090465 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Drugs for icu infection] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of colistin Plus tigecycline vs colsitin plus meropenem in treating hospital aquired acinetobacter boumanii infection |
|
Scientific Title of Study
|
Comparison of the Efficacy of Colistin Plus Tigecycline vs. Colistin Plus Meropenem in the Treatment of Carbapenem-Resistant Acinetobacter baumannii (CRAB): A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
FARHEEN ahmed |
| Designation |
Senior Resident |
| Affiliation |
AIIMS patna |
| Address |
B5A OT complex IPD building department of anaesthesiology All india institute of medical sciences phulwarisharif patna
Patna
BIHAR
801507
India |
| Phone |
07667393758 |
| Fax |
|
| Email |
FRHNAHMEDOC20@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room no 502 B5A Ot complex IPd building department of anesthesiology,All India institute of Mecial Sciences patna Phulwarishariff patna BIHAR India
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room no 502 B5A Ot complex IPd building department of anesthesiology,All India institute of Mecial Sciences patna Phulwarishariff patna BIHAR India
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna Bihar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna Bihar |
| Address |
Room no 502 B5A Ot complex IPd building department of anesthesiology,All India |
| Type of Sponsor |
Government medical college |
|
|
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 Farheen Ahmed |
AIIMS Patna |
Room no 502 B5A Ot complex IPd building department of anesthesiology,All India institute of Mecial Sciences patna Phulwarishariff patna BIHAR India
Patna
BIHAR |
07667393758
frhnahmedoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Colistin plus Meropenem |
Combination of Colistin 9 Lakh IU Loading f/b (4.5 lakh IV BD) with high dose of meropenem(2 gm iv over 3 hour as infusion 8 hourly) |
| Intervention |
Colistin plus tigecycline |
Combination of tigecycline loading dose of 200 mg IV and then (100 mg IV BD) plus colistin 9 Lakh IU Loading f/b (4.5 lakh IV BD) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients with VAP/HAP/BSI who are admitted with culture positive Acinetobacter baumanii in medical ICU.
2. Those who give consent for the study
|
|
| ExclusionCriteria |
| Details |
1. Non-Acinetobacter baumanii VAP/HAP/BSI admitted in ICU
2. Superimposed infection during the treatment of CRAB infection
3. Extremes of age-Age less than 18 and more than 70 years of age
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mortality
|
Mortality will be seen within 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comorbid conditions, Physiological scores (APACHE II), microbiological clearance (14 & 28 days),Clinical response to drugs (14 & 28 days)
|
All the comorbid conditions like Diabetes, Hypertension, CVA, neuromuscular disease, valvular heart disease will be noted on day 0 of admission
APACHE II score on day 0 of admission
Microbiological response success will be assessed by clearance of organism in repeat culture at day 14 & 28
Clinical response success will be assessed by improvement in Glasgow coma scale (GCS), Improvement in P/F ratio, decrease in ionotropic support at day 14 & 28 |
|
|
Target Sample Size
|
Total Sample Size="370"
Sample Size from India="370"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/07/2025 |
| 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 Yet Recruiting |
| 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
|
ยท Acinetobacter baumannii has evolved as a significant hospital pathogen by its ability to resist desiccation. Carbapenem resistance rates exceed 90%.Mortality rates for the most common CRAB infections, i.e., hospital-acquired pneumonia (HAP) and bloodstream infections (BSI), may approach 60%. Current antimicrobials for CRAB are polymyxins, tigecycline, and sometimes aminoglycosides. Various combinations of these drugs have been used for the treatment of CRAB infections. Combination therapies may be better at microbiologic eradication but not superior to monotherapy .This study will help in guiding the efficacy of combination therapy to inspire further novel therapeutic options against resistant microorganisms |