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CTRI Number  CTRI/2024/02/062539 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 14/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the outcome of patients treated with a combination of two or three antimicrobial drugs for the treatment of pneumonia (developed during mechanical ventilator stay) caused by microbe Acinetobacter Baumannii resistant to the commonly used broad spectrum antimicrobial (carbepenem). 
Scientific Title of Study   Efficacy of Triple vs Double drug regimens with at least two sensitive antibiotics on the outcome of patients infected with ventilator-associated pneumonia due to carbepenam-resistant Acinetobacter Baumannii: A randomised controlled study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadik Mohammed 
Designation  Additional Professor 
Affiliation  AIIMS, JODHPUR 
Address  Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, All India Institute of Medical Sciences (AIIMS), HI Area phase II, Basni, Jodhpur, Rajasthan.
As Above
Jodhpur
RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sadik Mohammed 
Designation  Additional Professor 
Affiliation  AIIMS, JODHPUR 
Address  Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, All India Institute of Medical Sciences (AIIMS), HI Area phase II, Basni, Jodhpur, Rajasthan.
As Above

RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sadik Mohammed 
Designation  Additional Professor 
Affiliation  AIIMS, JODHPUR 
Address  Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, All India Institute of Medical Sciences (AIIMS), HI Area phase II, Basni, Jodhpur, Rajasthan.
As Above

RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur  
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  Phase II, Basani Industrial Area, Jodhpur. 342005 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Sadik Mohammed  AIIMS, JODHPUR   Department of Anaesthesiology and Critical Care, 3rd Floor, DnT Block, AIIMS, Phase II, Basani Industrial Area, Jodhpur.
Jodhpur
RAJASTHAN 		 9414849733

drmsadik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A488||Other specified bacterial diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dual Drug Regimen  Patients will receive either minocycline 200mg bd with sulbactam high dose if sensitive to minocycline or polymyxin with high dose sulbactam if minocycline resistant. 
Intervention  Triple Drug Regimen  Patients will receive minocycline 200mg bd with polymyxin and high dose sulbactam irrespective of minocycline sensitivity. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Having ventilator-associated pneumonia (VAP) infection due to Carbepenam resistant A. Baumannii (CRAB) during ICU stay. 
 
ExclusionCriteria 
Details  1. Consent not obtained
2. Pregnant patients
3. Not treated for the infection
4. Infection not likely
5. Allergy to any drug used in the regimen
 
 
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 
Comparison of 28-day all-cause mortality between triple and
dual antibiotic drug regimen for VAP infection due to CRAB. 		 Comparison of 28-day all-cause mortality between triple and
dual antibiotic drug regimen for VAP infection due to CRAB. 
 
Secondary Outcome  
Outcome  TimePoints 
Microbiological clearance, length of ventilator stay, length of ICU stay, antibiotic treatment duration, in-hospital mortality, secondary infections post-CRAB infection.  During Hospital stay. 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
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)   15/02/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On personal request by mail at drmsadik@gmail.com

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The present randomised controlled single-blinded study shall be conducted in adult intensive care at AIIMS JODHPUR after obtaining written informed consent from the patients/patient’s relatives and approval from the institutional ethical committee. The study shall be prospectively registered with a clinical trial registry. Adult patients admitted to the intensive care unit for the duration of our study and meeting our inclusion criterion shall be included in the study. They shall be randomised into two groups using the block randomisation technique where one group will receive dual therapy while the other will receive triple therapy containing at least two sensitive drugs in each. The dual therapy will receive either minocycline 200mg bd with sulbactam high dose if sensitive to minocycline or polymyxin with high dose sulbactam if minocycline resistant. The triple therapy regimen will receive minocycline 200mg bd with polymyxin and sulbactam irrespective of minocycline sensitivity.
The baseline APACHE 2 score and SOFA score at treatment initiation and 48 hours after initiation shall be measured. Crossover from dual to triple therapy will be considered if SOFA rises more than 2 post-treatment initiation or persistence of microbiological positivity at day 4 from treatment initiation.
 
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