A Phase 2/3 interventional study of colistimethate sodium and 0.9% Saline in Ventilator Associated Pneumonia, sponsored by University Hospital Fattouma Bourguiba. Not yet recruiting. Open to participants aged 1 Month to 14 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University Hospital Fattouma Bourguiba · Phase 2/3, Interventional, and Prevention
The goal of this clinical trial is to learn if nebulized colistimethate sodium can prevent pneumonia in ventilated children. The main question it aims to answer is:
Participants will:
The COLIPED investigation is made of phase I (COLIPED I), phase II (COLIPED II) and phase III (COLIPED III) trials. COLIPED I is a monocenter prospective observational study aimed at assessing the clinical tolerance of nebulised CMS administered over 2 to 5 days at high doses to infants and children less than 14-year old. COLIPED II and III are double-blind, multicenter randomised controlled trials. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistimethate sodium twice daily for 2 to 5 days or inhaled placebo (0.9% Sodium Chloride). Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28.COLIPED II will be conducted in PICUs with VAP prevalance greater than 20%, COLIPED III will be conducted in PICUs with VAP prevalence ranging between 10 to 20%
392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.
This study's planned enrollment of 400 is above the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →University Hospital Fattouma Bourguiba is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Colistin group: In the Nebulized colistimethate sodium (CMS) group, 100 000 IU/kg of CMS (equivalent to 0.96 mg/kg of colistin base), will be nebulized daily, divided into two doses. The lyophilisate of CMS will be reconstituted as follows: 2 million of IU is reconstituted in 6mL of sterile 0.9% saline. The adequate volume is then withdrawn and compleated by 0.9% saline to reach a total volume of 6 ml that is administered immediately to mechanically ventilated patients via a nebulizer until the nebulized solution container becomes empty. The nebulization is administered from day 3 of invasive mechanical ventilation, twice daily for a maximum of 5 days or until extubation (whichever occurres first). \*12500 International Units of colistimethate sodium = 1 mg colistimethate sodium = 0.4 mg of colistin base.
Drug: colistimethate sodium
Nebulization of 6 ml of 0.9% saline twice a day for a maximum of 5 days from day 3 of invasive mechanical ventilation will be administered via a nebulizer until the nebulized solution container becomes empty.
Drug: 0.9% Saline
100 000 IU/kg of colistimethate sodium (equivalent to 0.96 mg/kg of colistin base) , will be nebulized daily, divided into two doses for a maximum of 5 days for eligible ventilated children starting from day 3 of mechanical ventilation.
Also known as: Colistin
Nebulization of 6 ml of 0.9% saline twice a day for a maximum of 5 days from day 3 of invasive mechanical ventilation for eligibile ventilated children
Also known as: normal saline
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
Time frame: From randomization to 28 days post-randomization
Incidence of Ventilation Associated Tracheobronchitis
Incidence of first episode of ventilation associated tracheobronchitis (VAT) from randomization to day 28.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 28 days from ICU admission
No study locations are listed for this record.
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Sap, Icf
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pneumonia, Ventilator-Associated→
University Hospital Fattouma Bourguiba