Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia
NCT Number: NCT06488794
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Ventilator Associated Pneumonia
Interventions: DRUG: colistimethate sodium|DRUG: 0.9% Saline
Sponsor: University Hospital Fattouma Bourguiba
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2026-04-01

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.

Primary Outcome Measures: Incidence of Ventilation Associated Pneumonia, Primary outcome will be the incidence of a first episode of ventilation associated pneumonia from randomization to day 28. Incidence will be calculated as the ratio of the number of patients experiencing a first VAP episode divided by the number of randomized patients, From randomization to 28 days post-randomization
Secondary Outcome Measures: Incidence of Ventilation Associated Tracheobronchitis, Incidence of first episode of ventilation associated tracheobronchitis (VAT) from randomization to day 28., From randomization to 28 days post-randomization|Incidence of a first episode of VAP and VAT in the subgroup of patients with tracheobronchial bacterial colonization at randomization, This secondary outcome measures the incidence of the first episode of ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT) within the first 28 days post-randomization in patients who had tracheobronchial bacterial colonization at the time of randomization. The 28-day period is selected to capture early occurrences of these infections and to evaluate the effectiveness of preemptive colistin nebulization in this high-risk subgroup., From randomization to 28 days post-randomization|Number of days spent on mechanical ventilation from randomization to day 28, This secondary outcome measures the total number of days a patient remains on mechanical ventilation within the first 28 days following randomization. The 28-day period is chosen to assess the impact of preemptive colistin nebulization on reducing the duration of mechanical ventilation during the critical initial phase of ICU treatment., From randomization to 28 days post-randomization|Number of days without systemic antibiotics from randomization to day 28, This secondary outcome measures the number of days without systemic antibiotic use within the first 28 days after randomization. The 28-day period is chosen to assess the impact of preemptive colistin nebulization on reducing the requirement for systemic antibiotics during the initial critical period of ICU treatment, From randomization to 28 days post-randomization|ICU stay, Number of days spent in the ICU after randomization. This secondary outcome measures the length of stay in the ICU, defined as the number of days from randomization to ICU discharge. The time frame is chosen to comprehensively assess the duration of ICU treatment, which may be affected by the incidence of ventilator-associated pneumonia (VAP) and the impact of preemptive colistin nebulization on patient recovery, From randomization to ICU discharge, up to 60 days|Incidence of antibiotic-resistant bacteria, This secondary outcome measures the incidence of antibiotic-resistant bacteria isolated from routine clinical and hygiene samples collected from the date of randomization until ICU discharge. The time frame is chosen to monitor the development and prevalence of antibiotic-resistant bacteria throughout the entire ICU stay, providing insights into the impact of preemptive colistin nebulization on bacterial resistance patterns., From randomization to ICU discharge|ICU day-28 mortality, This secondary outcome measures the mortality rate within 28 days of ICU admission. The time frame of 28 days is selected to assess early mortality outcomes related to ventilator-associated pneumonia and to evaluate the potential impact of preemptive colistin nebulization on patient survival during the initial critical period., 28 days from ICU admission