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CTRI Number  CTRI/2025/09/094280 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of three antibiotic combination with two antibiotic combination for treatment of lung infection in patients on ventilator 
Scientific Title of Study   A randomised controlled trial of sulbactam based 3-drug vs 2-drug regimen for treatment of Carbapenem-Resistant Acinetobacter baumannii ventilator associated pneumonia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shailendra Pratap Singh  
Designation  SENIOR RESIDENT 
Affiliation  AIIMS, New Delhi 
Address  Department of anaesthesi0logy, pain medicine and critical care AIIMS Ansari nagar New Delhi Pin 110029

South
DELHI
110029
India 
Phone  9211531101  
Fax    
Email  shaily55355@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kelika prakash 
Designation  Associate professor 
Affiliation  AIIMS, NEW DELHI 
Address  Department of anaesthesiology, pain medicine and critical care AIIMS Ansari nagar New Delhi Pin 110029

South
DELHI
110029
India 
Phone  9540947117  
Fax    
Email  kelika.prakash@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kelika prakash 
Designation  Associate professor 
Affiliation  AIIMS, NEW DELHI 
Address  Department of anaesthesiology, pain medicine and critical care AIIMS Ansari nagar New Delhi Pin 110029

South
DELHI
110029
India 
Phone  9540947117  
Fax    
Email  kelika.prakash@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, ANSARI NAGAR, NEW DELHI, 110029 
 
Primary Sponsor  
Name  Department of Anaesthesiology, Pain medicine and Critical care 
Address  Department of Anaesthesiology, Pain medicine and Critical care,Room no 5011, 5th floor, Teaching block, Ansari nagar, New Delhi-110029 AIIMS, Ansari nagar, 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shailendra pratap singh  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI  Department of Anaesthesia, Pain medicine and Critical care, 5th floor, Academic block building
South
DELHI 		 9599830058

shaily55355@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J156||Pneumonia due to other Gram-negative bacteria,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Group A :3 drug sulbactam based regimen   1. Polymyxin B: Intravenous (IV) loading dose of 25,000 IU/kg actual body weight, followed by 12,500 IU/kg every 12 hours. 2. Sulbactam: 3 gm sulbactam given as an infusion over 4 hours administered 8 hourly, total dose of 9 grams/day. 3. Minocycline: 200 mg IV every 12 hours. • Total Duration of intervention: 7 days  
Comparator Agent  Group B : 2 drug sulbactam based regimen  1. Sulbactam: Administered as 3 gm sulbactam given as an infusion over 4 hours administered 8 hourly total dose of 9 grams/day. and Minocycline: 200 mg IV every 12 hours. or Polymyxin B :25,000 IU/kg followed by 12,500 IU/kg every 12 hours. The second drug will be minocycline if sensitive on culture otherwise Polymyxin B will be chosen as second drug. • Total Duration of intervention: 7 days  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosed as Ventilator associated pneumonia as per CDC definition with tracheal aspirate/ BAL cultures positive for Carabapenem Resistant Acinetobacter Baumannii(CRAB) but susceptible to Polymyxin and Minocycline

 
 
ExclusionCriteria 
Details  1. Refusal to participate or lack of written informed consent
2. Known allergies to study drugs
3. Pregnant patients and lactating mothers
4. Poly-microbial VAP
5. Patients not expected to survive beyond study period
6. Pulmonary disease that precludes evaluation of therapeutic response eg lung cancer/lung metastases/active tuberculosis
7. Patients already on RRT at the start of treatment
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical Cure Rate at Day 8: Defined as complete resolution of VAP symptoms and signs (e.g., normalized temperature, white blood cell count, oxygenation, and no purulent secretions) by Day 8 of treatment.  Day 8 of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Microbiological Eradication at Day 8: No growth of CRAB in respiratory samples (ETA or BAL) on Day 8 of treatment.  Day 8 of treatment 
Clinical Improvement at Day 8 of treatment : Partial resolution of VAP symptoms and signs (e.g., improved oxygenation, reduced fever, or purulent secretions)  Day 8 of treatment 
Clinical Failure rates : Persistence or worsening of VAP symptoms and signs  Day 8 of treatment 
ICU Length of Stay (LOS): Duration from randomization to ICU discharge  Time from randomization to ICU discharge 
28-Day Mortality: All-cause mortality within 28 days from randomization.  Day 28 after randomization 
Incidence of Acute Kidney Injury (AKI)  Day 8 of treatment 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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 3 
Date of First Enrollment (India)   15/09/2025 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shaily55355@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 31-10-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is prospective, single blinded, parallel group, superiority randomized controlled trial at the ICUs of AIIMS, New Delhi. The study aims  to evaluate whether a three drug sulbactam based regimen comprising of sulbactam, polymyxin b and minocycline is superior to a two drug sulbactam based regimen of sulbactam and  minocycline for the treatment of ventilator associated pneumonia caused by carbapenem resistant Acinetobacter baumannii also known as CRAB VAP.
A total of 126 adult patients with microbiologically confirmed CRAB VAP susceptible to polymyxin b and minocycline will be enrolled. Patients will be randomized using variable permuted block randomization into two groups to receive either three drug or two drug regimen for 7 days. The primary outcome is clinical cure at 8 days defined as complete resolution of signs and symptoms of pneumonia. Secondary outcomes will be microbiological eradication, clinical improvement or failure, ICU length of stay, 28 day mortality , incidence of acute kidney injury and adverse drug events.
The rationale stems from limited availability of newer antibiotics and the growing resistance to existing drugs in India. Preliminary observational and in vitro studies have shown reduced mortality with three drug regimen and synergy between sulbactam, polymyxin b and minocycline using pharmacodynamic models. This study seeks to provide high quality evidence to guide treatment protocols for CRAB VAP infections which  has high incidence in ICUs, is associated with high mortality rates  and has limited therapeutic options.
 
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