Ventilator Associated Pneumonia
Conditions
Keywords
colistin, mechanical ventilation, pneumonia, nebulization, prevention, pediatrics
Brief 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.
Detailed description
The COLIPED investigation is made of phase I (COLIPED I), phase II (COLIPED II) and phase III (COLIPED III) trials. COLIPED I is a monocenter prospective observational study aimed at assessing the clinical tolerance of nebulised CMS administered over 3 to 7 days at high doses to infants and children less than 14-year old. COLIPED II and III are double-blind, multicenter randomised controlled trials. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistimethate sodium 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.COLIPED II will be conducted in PICUs with VAP prevalance greater than 20%, COLIPED III will be conducted in PICUs with VAP prevalence ranging between 10 to 20%
Interventions
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.
DRUG0.9% 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
University Hospital Fattouma Bourguiba
the European Investigators Research Network for Nebulised Antibiotics in Ventilator-Associated Pneumonia
University General hospital of Larissa, University of Thessaly, Larissa, Greece
Cukurova University School of Medicine, Adana, Turquey
University general Hospital of Heraklion, University of Crete, Heraklion, Greece
Osmangazi University School of Medicine, Eskişehir, Turkey
Agia Sofia Children's Hospital, Athens, Greece
P&A Aglaia Kyriakou Children's hospital, Athens, Greece
University General hospital Attikon, Athens, Greece
Gazi University School of Medicine, Ankara, Turquey
Cerrahpaşa University School of Medicine, Istambul, Turquey
Marmara University School of Medicine, Istambul, Turquey
Başakşehir Çam ve Sakura Hospital, Istambul, Turquey
Hôpital Mère-Enfant Abderrahim HAROUCHI University hospital ibn Rochd Casablanca, Morrocco
Hadi Cheker university hospital, sfax, Tunisia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ventilation Associated Pneumonia | From randomization to 28 days post-randomization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ventilation Associated Tracheobronchitis | From randomization to 28 days post-randomization | 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 | From randomization to 28 days post-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 | From randomization to 28 days post-randomization | 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 | From randomization to 28 days post-randomization | 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 |
| ICU stay | From randomization to ICU discharge, up to 60 days | Number of days spent in the ICU after randomization. This secondary outcome measures the length of stay in the ICU, defined as the number of days from randomization to ICU discharge. The time frame is chosen to comprehensively assess the duration of ICU treatment, which may be affected by the incidence of ventilator-associated pneumonia (VAP) and the impact of preemptive colistin nebulization on patient recovery |
| Incidence of antibiotic-resistant bacteria | From randomization to ICU discharge | This secondary outcome measures the incidence of antibiotic-resistant bacteria isolated from routine clinical and hygiene samples collected from the date of randomization until ICU discharge. The time frame is chosen to monitor the development and prevalence of antibiotic-resistant bacteria throughout the entire ICU stay, providing insights into the impact of preemptive colistin nebulization on bacterial resistance patterns. |
| ICU day-28 mortality | 28 days from ICU admission | This secondary outcome measures the mortality rate within 28 days of ICU admission. The time frame of 28 days is selected to assess early mortality outcomes related to ventilator-associated pneumonia and to evaluate the potential impact of preemptive colistin nebulization on patient survival during the initial critical period. |
Contacts
CONTACTFarah C Thabet, MD
Outcome results
None listed