Intermittent vs Continous infusion of colistin in VAP

Not yet recruiting

Conditions: Unspecified bacterial pneumonia,

Registration Number: CTRI/2019/04/018847

Lead Sponsor: dr simranpreet singh

Brief Summary: Sepsis is one of the mostcommon cause of mortality in PICUs worldwide. Although many children are admittedin critical care units with sepsis or related complications, nosocomial sepsis contributesa significant burden with incidence of 2.8-21.6% as per various studies. Bacterialsepsis constitutes the majority of nosocomial infections. Ventilator associatedpneumonia (VAP) is among the most frequently occurring nosocomial infection inthe PICU and has been associated with increased morbidity, prolonged durationof ventilation and increased cost. Although both gram positive and negative organismsare known to cause VAP, gram negative pathogens predominate in the PICU settings..Resistant Gram negative pathogens inPICU have emerged as a significant problem over the past few decades. Colistinhas reemerged as a useful antibiotic for resistant gram negative organisms andnow represents a therapy of last resort. The standard practice is to administerintravenous colistin in intermittent dosing thrice a day. The use of continousinfusion method has been documented in some clinical studies. The clinicalVAP diagnosis as well as outcome is currently assessed by Clinical PulmonaryInfection Score described first by Pugin et al13. Presentlyin our hospital we deal with a large number of patients with VAP caused by gramnegative organisms. The recent emergence of drug resistant strains has been aconcern leading to use of colistin as per our present PICU antibiotic protocol.The concept of loading dose and time averaged long exposures have beensuggested 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 yearin a 12-bed multidisciplinary pediatriccritical care unit (PICU) at Sir Ganga Ram hospital in Delhi after obtainingethical clearance. Children of age 1 month to 18yrs suffering from VAP as perCPIS score and microbiological evidence will be included. They will be randomizedinto receiving intermittent and continous dosing of colistin. Endpoints will benegative CPIS scores and microbiological clearance at completion of therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Children of age 1 month to 18yrs suffering from VAP as per CPIS score and microbiological evidence of gram negative organism in culture specimen.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Sir Gangaram hospital
🇮🇳
Central, DELHI, India
Sir Gangaram hospital
🇮🇳Central, DELHI, India
Dr Simranpreet Singh
Principal investigator
09915505902
simran60422@gmail.com