Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-30 @ 9:46 AM
Study NCT ID:
NCT06488794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2024-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia
Sponsor:
University Hospital Fattouma Bourguiba
Organization:
Study Overview
Official Title:
Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia: A Double Blind Multicenter Randomized Controlled Trial Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ColiPed
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 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.
• 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.
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 of ventilator-associated pneumonia.
A double-blind, multicenter randomized controlled trial will be conducted. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistin twice daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28.
A double-blind, multicenter randomized controlled trial will be conducted. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistin twice daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: