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Search / Trial NCT06488794

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

Colistin Mechanical Ventilation Pneumonia Nebulization Prevention Pediatrics

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.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported