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.
Children older than 1 month and younger than 14 years
Patients on invasive mechanical ventilation for more than 48 hours
Informed parental consent
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
University Hospital Fattouma Bourguiba
Lead sponsor
University of Monastir
Sponsor institution
the European Investigators Research Network for Nebulised Antibiotics in Ventilator-Associated Pneumonia
Collaborator
University General hospital of Larissa, University of Thessaly, Larissa, Greece
Collaborator
Cukurova University School of Medicine, Adana, Turquey
Collaborator
University General Hospital of Heraklion
Collaborator
Osmangazi University School of Medicine, Eskişehir, Turkey
Collaborator
Aghia Sophia Children's Hospital of Athens
Collaborator
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Collaborator
Attikon Hospital
Collaborator
Gazi University School of Medicine, Ankara, Turquey
Collaborator
Cerrahpaşa University School of Medicine, Istambul, Turquey
Collaborator
Marmara University School of Medicine, Istambul, Turquey
Collaborator
Başakşehir Çam ve Sakura Hospital, Istambul, Turquey
Collaborator
Hôpital Mère-Enfant Abderrahim HAROUCHI University hospital ibn Rochd Casablanca, Morrocco
Collaborator
Hadi Cheker university hospital, sfax, Tunisia
Collaborator