Status:
NOT_YET_RECRUITING
Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia
Lead Sponsor:
University Hospital Fattouma Bourguiba
Conditions:
Ventilator Associated Pneumonia
Eligibility:
All Genders
1-14 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to learn if nebulized colistimethate sodium can prevent pneumonia in ventilated children. The main question it aims to answer is: • Does nebulized colistimethate so...
Detailed Description
The aim of the study is to evaluate the benefit of a 3 to 7 day course of inhaled colistimethate sodium among children undergoing invasive mechanical ventilation for more than 2 days on the occurrence...
Eligibility Criteria
Inclusion
- Children older than 1 month and younger than 14 years
- Patients on invasive mechanical ventilation for more than 48 hours
- Informed parental consent
Exclusion
- Suspected or confirmed VAP on the day of inclusion
- Indication for systemic colistin therapy before or at enrolment in the study
- Plan for extubation within the next 24H
- Known allergy to colistin
- No parental consent
- Tracheostomy
- Appearance of allergic clinical manifestations in the days of colistin nebulization
- Appearance of undesirable clinical or biological manifestations presumed attributable to nebulization with colistin
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06488794
Start Date
October 1 2025
End Date
April 1 2027
Last Update
June 10 2025
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