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
|
|
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
|
|
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. |