Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-15
Brief Title:
Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia
Sponsor:
University Hospital Fattouma Bourguiba
Organization:
University Hospital Fattouma Bourguiba
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:
2024-06
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:
None
Brief Summary:
The goal of this clinical trial is to learn if nebulized colistin can prevent pneumonia in ventilated children The main question it aims to answer is
Does nebulized colistin lower the number of times participants develop ventilation associated pneumonia Researchers will compare nebulized colistin 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 Colistin or a placebo twice a day for 3 days
Will be followed to check for pneumonia occurrence while they are on mechanical ventilation
Does nebulized colistin lower the number of times participants develop ventilation associated pneumonia Researchers will compare nebulized colistin 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 Colistin or a placebo twice a day for 3 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-day course of inhaled colistin 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 09 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 09 Sodium Chloride Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28
Study Oversight
Has Oversight DMC:
None
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?:
None