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NCT Number: NCT06488794

Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia

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.

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colistimethate sodium

Drug

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.

Other names: Colistin

0.9% saline

Drug

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

Other names: normal saline

Primary outcomes

  1. Incidence of Ventilation Associated Pneumonia

    Time frame: 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 outcomes

  1. Incidence of Ventilation Associated Tracheobronchitis

    Time frame: From randomization to 28 days post-randomization

    Incidence of first episode of ventilation associated tracheobronchitis (VAT) from randomization to day 28.

  2. Incidence of a first episode of VAP and VAT in the subgroup of patients with tracheobronchial bacterial colonization at randomization

    Time frame: 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.

  3. Number of days spent on mechanical ventilation from randomization to day 28

    Time frame: 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.

  4. Number of days without systemic antibiotics from randomization to day 28

    Time frame: 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

  5. ICU stay

    Time frame: 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

  6. Incidence of antibiotic-resistant bacteria

    Time frame: 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.

  7. ICU day-28 mortality

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Farah C Thabet, MD

CONTACT

[email protected]

0021629742011

Sponsors and collaborators

Lead sponsor

University Hospital Fattouma Bourguiba

Other

Collaborators

  • Aghia Sophia Children's Hospital of Athens
  • Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
  • Attikon Hospital
  • Başakşehir Çam ve Sakura Hospital, Istambul, Turquey
  • Cerrahpaşa University School of Medicine, Istambul, Turquey
  • Cukurova University School of Medicine, Adana, Turquey
  • Gazi University School of Medicine, Ankara, Turquey
  • Hadi Cheker university hospital, sfax, Tunisia
  • Hôpital Mère-Enfant Abderrahim HAROUCHI University hospital ibn Rochd Casablanca, Morrocco
  • Marmara University
  • Osmangazi University School of Medicine, Eskişehir, Turkey
  • University General Hospital of Heraklion
  • University General hospital of Larissa, University of Thessaly, Larissa, Greece
  • the European Investigators Research Network for Nebulised Antibiotics in Ventilator-Associated Pneumonia

Registry information

Official study title

Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia: The COLIPED Investigation

Acronym: ColiPed

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jul 5, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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