FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/04/018847 [Registered on: 30/04/2019] Trial Registered Prospectively
Last Modified On: 26/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [antibiotic efficacy comparison]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intermittent vs Continous infusion of colistin in VAP 
Scientific Title of Study   To compare the efficacy of standard intermittent dose regime and continous infusion of intravenous colistin in the treatment of ventilator associated pneumonia in PICU patients - A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Simranpreet Singh 
Designation  PICU Fellow 
Affiliation  FNB resident. Sir gangaram hospital 
Address  Pediatric ICU,Division of pediatric emergency,critical care and allergic disorders. Sir Gangaram hospital,New Delhi

Central
DELHI
110060
India 
Phone  9915505902  
Fax    
Email  simran60422@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Sachdev 
Designation  Director 
Affiliation  PICU incharge. Sir gangaram hospital 
Address  Pediatric ICU,Division of pediatric emergency,critical care and allergic disorders. Sir Gangaram hospital,New Delhi

Central
DELHI
110060
India 
Phone  9810098360  
Fax    
Email  anilcriticare@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SIMRANPREET SINGH 
Designation  PICU Fellow 
Affiliation  FNB resident. Sir gangaram hospital 
Address  Pediatric ICU,Division of pediatric emergency,critical care and allergic disorders. Sir Gangaram hospital,New Delhi

Central
DELHI
110060
India 
Phone  9915505902  
Fax    
Email  simran60422@gmail.com  
 
Source of Monetary or Material Support  
sir gangaram hospital,new delhi 110060 
 
Primary Sponsor  
Name  dr simranpreet singh 
Address  Pediatric ICU, Sir Gangaram hospital,New Delhi,110060 
Type of Sponsor  Other [self] 
 
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 Simranpreet Singh  Sir Gangaram hospital  Pediatric ICU,Division of pediatric emergency,critical care and allergic disorders. Sir Gangaram hospital,New Delhi
Central
DELHI 
09915505902

simran60422@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sir gangaram hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J159||Unspecified bacterial pneumonia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Use of 2 different modes of administration of an antibiotic and compare the efficacy.  Use of Colistin as Continous infusion regime in gram negative Ventilator Associated Pneumonia 
Intervention  Use of 2 different modes of administration of an antibiotic and compare the efficacy.  Use of Colistin in gram negative Ventilator Associated Pneumonia as Intermittent dosing regime. 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children of age 1 month to 18yrs suffering from VAP as per CPIS score and microbiological evidence of gram negative organism in culture specimen 
 
ExclusionCriteria 
Details  any patient with gram positive organism growth or sensitivity to a lower class of antibiotic. Also patients who leave against medical advice or those with untimely mortality during study duration 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of intermittent dose regime and continuous infusion of intravenous colistin in terms of clinical and microbiological outcome in the treatment of children with ventilator associated pneumonia.  Negative CPIS scores and microbiological clearance documentation in the diagnostic specimen at day 4 or day 7 of treatment whichever applicable 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study any difference in incidence of adverse effects of colistin when given by either of these methods  Negative CPIS scores and microbiological clearance documentation in the diagnostic specimen on day 4 or day 7 of treatment whichever applicable 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/05/2019 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Sepsis is one of the most common cause of mortality in PICUs  worldwide. Although many children are admitted in critical care units with sepsis or related complications, nosocomial sepsis contributes a significant burden with incidence of 2.8-21.6% as per various studies. Bacterial sepsis constitutes the majority of nosocomial infections. Ventilator associated pneumonia (VAP) is among the most frequently occurring nosocomial infection in the PICU and has been associated with increased morbidity, prolonged duration of ventilation and increased cost. Although both gram positive and negative organisms are known to cause VAP, gram negative pathogens predominate in the PICU settings.. Resistant Gram negative pathogens  in PICU have emerged as a significant problem over the past few decades. Colistin has reemerged as a useful antibiotic for resistant gram negative organisms and now represents a therapy of last resort. The standard practice is to administer intravenous colistin in intermittent dosing thrice a day. The use of continous infusion method has been documented in some clinical studies. The  clinical VAP diagnosis as well as outcome is currently assessed by Clinical Pulmonary Infection Score described first by Pugin et al13. Presently in our hospital we deal with a large number of patients with VAP caused by gram negative organisms. The recent emergence of drug resistant strains has been a concern leading to use of colistin as per our present PICU antibiotic protocol. The concept of loading dose and time averaged long exposures have been suggested in past studies as the basis of continous infusion colistin protocol. This study will be a time bound study conducted over a period of one year in  a 12-bed multidisciplinary pediatric critical care unit (PICU) at Sir Ganga Ram hospital in Delhi after obtaining ethical clearance. Children of age 1 month to 18yrs suffering from VAP as per CPIS score and microbiological evidence will be included. They will be randomized into receiving intermittent and continous dosing of colistin. Endpoints will be negative CPIS scores and microbiological clearance at completion of therapy.

 
Close