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 5 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
Parallel
colistimethate sodium
Drug100 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.
0.9% Saline
DrugNebulization 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
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
Incidence of Ventilation Associated Tracheobronchitis
Incidence of first episode of ventilation associated tracheobronchitis (VAT) from randomization to day 28.
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.
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.
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
Click on the lead sponsor to view all of their trials.
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
Collaborator
Cerrahpaşa University School of Medicine, Istambul, Turquey
Collaborator
Marmara University
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
Research Laboratory LR12SP17
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
