Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia (ColiPed)

University Hospital Fattouma Bourguiba

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Ventilator Associated Pneumonia

Treatments: Drug: 0.9% Saline; Drug: colistimethate sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT06488794

FThabet

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 month to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

colistin group

Active Comparator group

Description:

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.

Treatment:

Drug: colistimethate sodium

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9% Saline