Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia
Launched by UNIVERSITY HOSPITAL FATTOUMA BOURGUIBA · Jun 28, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a medication called nebulized colistin can help prevent pneumonia in children who are on a ventilator. Pneumonia can be a serious condition that can occur in children using mechanical ventilation, and the researchers want to find out if using colistin, delivered through a nebulizer (a device that turns liquid medicine into a mist), can reduce the number of children who get this infection. To do this, some children will receive the colistin while others will receive a placebo, which is a look-alike substance with no active ingredients.
To be eligible for this study, children must be between the ages of 1 month and 14 years and have been on a ventilator for more than 48 hours. Parents will need to give their consent for their child to participate. If enrolled, children will take the nebulized medication or placebo twice a day for three days. Researchers will then monitor them for any signs of pneumonia while they are on the ventilator. It's important to note that this trial is not yet recruiting participants, so it won't start immediately.
Gender
ALL
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
- • 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
About University Hospital Fattouma Bourguiba
University Hospital Fattouma Bourguiba is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent academic medical center, it collaborates with a multidisciplinary team of healthcare professionals and researchers to conduct rigorous studies that address pressing health challenges. The hospital prides itself on its commitment to ethical standards, patient safety, and the integration of cutting-edge technologies in clinical research, ultimately aiming to enhance treatment outcomes and contribute to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported