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Clinical trial

Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia: A Double Blind Multicenter Randomized Controlled Trial Protocol

ID
Name
FThabet
Description
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.
Trial arms
Trial start
2024-10-01
Estimated PCD
2026-04-01
Trial end
2026-04-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
colistimethate sodium
30 000 IU/kg of colistimethate sodium (equivalent to 0.96 mg/kg of colistin base) ,maximum 750000 IU, will be nebulized daily, divided into two doses for 3 days for eligible ventilated children starting from day 3 of mechanical ventilation.
Arms:
colistin group
Other names:
Colistin
0.9% Saline
Nebulization of 3 ml of 0.9% saline twice a day for 3 days from day 3 of invasive mechanical ventilation for eligibile ventilated children
Arms:
Control group
Other names:
normal saline
Size
100
Primary endpoint
Incidence of Ventilation Associated Pneumonia
From randomization to 28 days post-randomization
Eligibility criteria
Inclusion Criteria: * Children older than 1 month and younger than 14 years * Patients on invasive mechanical ventilation for more than 48 hours * Informed parental consent Exclusion Criteria: * 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 * Colonization or infection with a germ resistant to colistin on admission * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-07-04

1 organization

1 product

1 drug

1 indication

Organization
University Hospital Fattouma Bourguiba
Product
Colistimethate
Indication
Ventilator-associated pneumonia
Drug
Varlilumab