Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia

Summary

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.

Conditions

• Ventilator Associated Pneumonia

Interventions

DRUG

colistimethate sodium

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 7 days for eligible ventilated children starting from day 3 of mechanical ventilation.

DRUG

0.9% Saline

Nebulization of 6 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

Sponsors & Collaborators

• the European Investigators Research Network for Nebulised Antibiotics in Ventilator-Associated Pneumonia

  collaborator UNKNOWN

• University General hospital of Larissa, University of Thessaly, Larissa, Greece

  collaborator UNKNOWN

• Cukurova University School of Medicine, Adana, Turquey

  collaborator UNKNOWN

• University general Hospital of Heraklion, University of Crete, Heraklion, Greece

  collaborator UNKNOWN

• Osmangazi University School of Medicine, Eskişehir, Turkey

  collaborator UNKNOWN

• Agia Sofia Children's Hospital, Athens, Greece

  collaborator UNKNOWN

• P&A Aglaia Kyriakou Children's hospital, Athens, Greece

  collaborator UNKNOWN

• University General hospital Attikon, Athens, Greece

  collaborator UNKNOWN

• Gazi University School of Medicine, Ankara, Turquey

  collaborator UNKNOWN

• Cerrahpaşa University School of Medicine, Istambul, Turquey

  collaborator UNKNOWN

• Marmara University School of Medicine, Istambul, Turquey

  collaborator UNKNOWN

• Başakşehir Çam ve Sakura Hospital, Istambul, Turquey

  collaborator UNKNOWN

• Hôpital Mère-Enfant Abderrahim HAROUCHI University hospital ibn Rochd Casablanca, Morrocco

  collaborator UNKNOWN

• Hadi Cheker university hospital, sfax, Tunisia

  collaborator UNKNOWN

• University Hospital Fattouma Bourguiba

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2028-12-31

Completion

2028-12-31