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CTRI Number  CTRI/2024/11/076911 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of the effectiveness and safety of the Intravenous colistin alone vs. intravenous colistin plus inhaled colistin in patients on ventilator having pneumonia  
Scientific Title of Study   Efficacy and safety of intravenous colistin plus nebulized colistin versus intravenous colistin alone in patients with clinically suspected ventilator-associated pneumonia: a single-centre prospective cohort 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  Manisha Maheshwari 
Designation  Post graduate Resident  
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Room no. 2211, 2nd floor, South Wing, Department of Pharmacology, Medical College building Gate no. 5, All India Institute of Medical Sciences Tatibandh, Raipur, Chhattisgarh 492099.

Raipur
CHHATTISGARH
492099
India 
Phone  8962799774  
Fax    
Email  agiwalmani994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin R Gaikwad 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Room no. 2218, 2nd floor, South Wing, Department of Pharmacology, Medical College building Gate no. 5 All India Institute of Medical Sciences Tatibandh, Raipur, Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone  8518881725  
Fax    
Email  nitingaikwad2707@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nitin R Gaikwad 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Room no. 2218, 2nd floor, South Wing, Medical College building Gate no. 5 All India Institute of Medical Sciences, Tatibandh Raipur, Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone  8518881725  
Fax    
Email  nitingaikwad2707@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Raipur, Tatibandh, Raipur, 492099 Chhattisgarh India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Raipur 
Address  All India Institute of Medical Sciences Tatibandh Raipur Chhattisgarh 492099 India 
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 
Dr Nitin R Gaikwad  All India Institute of Medical Sciences Raipur  Critical Care Unit, Department of Anaesthesiology,2nd floor Trauma building
Raipur
CHHATTISGARH 		 8518881725

nitingaikwad2707@aiimsraipur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J188||Other pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged 18 years or older
patients admitted to critical care unit for more than 48 hours
patients clinically suspected with ventilator associated pneumonia
patients who will be receiving intravenous colistin and/or nebulized colistin 
 
ExclusionCriteria 
Details  patients who will be discharged, leave against medical advise
patient who are re-admitted to ICU 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical Improvement in terms of - 1.decreased FiO2 (20% decreases from baseline)
2.decreased PEEP (3 cm of water decrease from baseline)
3.total leukocyte count (within normal range as compared to baseline)
4. decreased secretions or decrease in number of suctioning as compared to baseline
4. procalcitonin levels less than 0.05mcg/litre or 80% decrease from baseline 		 at baseline (for comparison), at end of3rd day  
 
Secondary Outcome  
Outcome  TimePoints 
clinical improvement  baseline, seventh day  
median length of ICU Stay   date of admission in ICU & date of discharge/death/transferred out from ICU 
median length of mechanical ventilation  date of intubation & date of extubation 
percentage of change in Clinical pulmonary infection score at admission & at completion of antibiotic therapy  at admission & after antibiotic therapy is completed 
all cause ICU mortality  between date of admission at ICU & date of discharge/death/transferred out 
incidence of AKI   baseline, 3rd day & 7th day 
incidence of bronchospasm  after each instance of nebulization 
culture conversion rate   baseline & after completing antibiotic therapy 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   29/11/2024 
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="1"
Months="6"
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 - 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 - Clinical Study Report

  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 [agiwalmani994@gmail.com].

  6. For how long will this data be available start date provided 30-06-2026 and end date provided 30-11-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   the study hypothesizes that intravenous colistin plus nebulized colistin improves clinical outcomes in patients with clinically suspected ventilator associated pneumonia compared to intravenous colistin alone. the primary objective is to see effectiveness of intravenous colistin plus nebulized colistin in the form of favourable clinical outcomes as composite end points as follows -  decreased Fio2, decreased PEEP, decreased secretions, total leukocyte count within normal range, pro-calcitonin levels 80% decrease from baseline. 
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