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CTRI Number  CTRI/2025/04/084715 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   How Molecular Testing Improves Diagnosis and Treatment of Ventilator Associated Pneumonia from Gram Negative Bacteria in ICU Patients 
Scientific Title of Study   Utility of molecular over traditional diagnostic method in diagnosis and management of ventilator associated pneumonia caused by Gram negative bacteria in intensive care unit 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna Priya Agrawal 
Designation  Senior Resident  
Affiliation  King Georges Medical University Lucknow  
Address  Department of Critical care medicine KGMU Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7895271264  
Fax    
Email  krishnapriyas2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Avinash Agrawal 
Designation  Head of Department Critical Care Medicine  
Affiliation  King Georges Medical University Lucknow 
Address  Department of Critical care medicine KGMU Lucknow.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9838677999  
Fax    
Email  avinashagrawal@kgmcindia.edu   
 
Details of Contact Person
Public Query  
Name  Prof Avinash Agrawal 
Designation  Head of Department Critical Care Medicine  
Affiliation  King Georges Medical University Lucknow 
Address  Department of Critical care medicine KGMU Lucknow.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9838677999  
Fax    
Email  avinashagrawal@kgmcindia.edu   
 
Source of Monetary or Material Support  
Department of critical care medicine King Georges medical university lucknow UTTAR PRADESH INDIA 226003 
 
Primary Sponsor  
Name  Dr Avinash Agrawal 
Address  Department of Critical Care Medicine King Georges Medical University Lucknow India 226003 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Krishna Priya Agrawal   Department of Critical Care Medicine King Georges Medical University Lucknow 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Krishna Priya Agrawal  King Georges Medical University Lucknow   Department of critical care medicine 5th floor trauma centre
Lucknow
UTTAR PRADESH 		 7895271264

krishnapriyas2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KGMU Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J189||Pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  patients having clinically defined VAP according to CDC
Age more than or equal to 18 years 
 
ExclusionCriteria 
Details  Patients with evidence of chest infection prior to intubation or within 48 hours of mechanical ventilation
Patients with severely immunocompromised state such as Acquired Immune Deficiency Syndrome organ transplant patients terminal stage of malignancy
Patients whose sample could not be obtained
Patients who are not willing to participate or give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the outcome 28 days mortality of early molecular identification of Gram negative organisms causing VAP and identification of common carbapenem resistant genes KPC IMP VIM NDM or OXA 48 compared with traditional culture methods  At baseline 4 weeks and 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the change in targeted antibiotic therapy selection according to molecular method and culture method  2 days 
To compare the change in Clinical Pulmonary Infection Score on third day of management on the basis of molecular method and culture method  3 days 
To compare the effect of diagnosis and management of VAP by both the methods on 90 days mortality  90 days 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
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)   24/04/2025 
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="6"
Days="1" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [krishnapriyas2012@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The study aims at evaluating the diagnostic performance of molecular based PCR compared to standard microbiological culture test
and the potential impact of its results on early modification of antimicrobial therapy along with clinical outcomes in  ICU patients with clinically defined VAP.
 
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