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Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia
Sponsor: University Hospital Fattouma Bourguiba
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 sodium lower the number of times participants develop ventilation associated pneumonia? Researchers will compare nebulized colistimethate sodium to a placebo (a look-alike substance that contains no drug) to see if nebulized colistin works to prevent ventilation associated pneumonia in children. Participants will: * Take nebulized colistimethate sodium or a placebo twice a day for a maximum of 7 days. * Will be followed to check for pneumonia occurrence while they are on mechanical ventilation.
Official title: Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia: The COLIPED Investigation
Key Details
Gender
All
Age Range
1 Month - 14 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2027-01-01
Completion Date
2028-12-31
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
colistimethate sodium
100 000 IU/kg of colistimethate sodium (equivalent to 0.96 mg/kg of colistin base) , will be nebulized daily, divided into two doses for a maximum of 7 days for eligible ventilated children starting from day 3 of mechanical ventilation.
0.9% Saline
Nebulization of 6 ml of 0.9% saline twice a day for a maximum of 7 days from day 3 of invasive mechanical ventilation for eligibile ventilated children