Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-04-01

Brief Summary

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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:

• Does nebulized colistimethate sodium lower the number of times participants develop ventilation associated pneumonia? Researchers will compare nebulized colistimethate sodium 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 colistimethate sodium or a placebo twice a day for a maximum of 7 days.
* Will be followed to check for pneumonia occurrence while they are on mechanical ventilation.

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Detailed Description

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The aim of the study is to evaluate the benefit of a 3 to 7 day course of inhaled colistimethate sodium among children undergoing invasive mechanical ventilation for more than 2 days on the occurrence of ventilator-associated pneumonia.

A double-blind, multicenter randomized controlled trial will be conducted. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistin twice daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28.

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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colistin group

Colistin group:

In the Nebulized colistimethate sodium (CMS) group, 100 000 IU/kg of CMS (equivalent to 0.96 mg/kg of colistin base), (maximum 750000 IU) will be nebulized daily, divided into two doses. The lyophilisate of CMS will be reconstituted as follows: 1 million of IU is reconstituted in 3 mL of sterile 0.9% saline. The adequate volume is then withdrawn and 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 7 days or until extubation (whichever occurres first).

\*12500 International Units of colistimethate sodium = 1 mg colistimethate sodium = 0.4 mg of colistin base.

Group Type ACTIVE_COMPARATOR

colistimethate sodium

Intervention Type DRUG

100 000 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 a maximum of 7 days for eligible ventilated children starting from day 3 of mechanical ventilation.

Control group

Nebulization of 3 ml of 0.9% saline twice a day for a maximum of 7 days from day 3 of invasive mechanical ventilation will be administered via a nebulizer until the nebulized solution container becomes empty.

Group Type PLACEBO_COMPARATOR

0.9% Saline

Intervention Type DRUG

Nebulization of 3 ml of 0.9% saline twice a day for a maximum of 7 days from day 3 of invasive mechanical ventilation for eligibile ventilated children

Interventions

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colistimethate sodium

100 000 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 a maximum of 7 days for eligible ventilated children starting from day 3 of mechanical ventilation.

Intervention Type DRUG

0.9% Saline

Nebulization of 3 ml of 0.9% saline twice a day for a maximum of 7 days from day 3 of invasive mechanical ventilation for eligibile ventilated children

Intervention Type DRUG

Other Intervention Names

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Colistin normal saline

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No