Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia

Официальное название

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

Обзор

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.

Подробное описание

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%

Вмешательства

• Препарат 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.
• Препарат 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

Первичные конечные точки

• Incidence of Ventilation Associated Pneumonia [Срок оценки: From randomization to 28 days post-randomization]

Вторичные конечные точки (7)

• Incidence of Ventilation Associated Tracheobronchitis [Срок оценки: From randomization to 28 days post-randomization]
• Incidence of a first episode of VAP and VAT in the subgroup of patients with tracheobronchial bacterial colonization at randomization [Срок оценки: From randomization to 28 days post-randomization]
• Number of days spent on mechanical ventilation from randomization to day 28 [Срок оценки: From randomization to 28 days post-randomization]
• Number of days without systemic antibiotics from randomization to day 28 [Срок оценки: From randomization to 28 days post-randomization]
• ICU stay [Срок оценки: From randomization to ICU discharge, up to 60 days]
• Incidence of antibiotic-resistant bacteria [Срок оценки: From randomization to ICU discharge]
• ICU day-28 mortality [Срок оценки: 28 days from ICU admission]

Критерии участия

Критерии включения

• Children older than 1 month and younger than 14 years
• Patients on invasive mechanical ventilation for more than 48 hours
• Informed parental consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Zhu Y, Monsel A, Roberts JA, Pontikis K, Mimoz O, Rello J, Qu J, Rouby JJ; European Investigator Network for Nebulized Antibiotics in Ventilator-Associated Pneumonia (ENAVAP). Nebulized Colistin in Ventilator-Associated Pneumonia and Tracheobronchitis: Historical Background, Pharmacokinetics and Perspectives. Microorganisms. 2021 May 27;9(6):1154. doi: 10.3390/microorganisms9061154. PMID 34072189
• Jang JY, Kwon HY, Choi EH, Lee WY, Shim H, Bae KS. Efficacy and toxicity of high-dose nebulized colistin for critically ill surgical patients with ventilator-associated pneumonia caused by multidrug-resistant Acinetobacter baumannii. J Crit Care. 2017 Aug;40:251-256. doi: 10.1016/j.jcrc.2017.04.004. Epub 2017 Apr 7. PMID 28458172
• Karvouniaris M, Makris D, Zygoulis P, Triantaris A, Xitsas S, Mantzarlis K, Petinaki E, Zakynthinos E. Nebulised colistin for ventilator-associated pneumonia prevention. Eur Respir J. 2015 Dec;46(6):1732-9. doi: 10.1183/13993003.02235-2014. Epub 2015 Sep 24. PMID 26405294
• Povoa FCC, Cardinal-Fernandez P, Maia IS, Reboredo MM, Pinheiro BV. Effect of antibiotics administered via the respiratory tract in the prevention of ventilator-associated pneumonia: A systematic review and meta-analysis. J Crit Care. 2018 Feb;43:240-245. doi: 10.1016/j.jcrc.2017.09.019. Epub 2017 Sep 18. PMID 28942198

Идентификаторы

NCT: NCT06488794 · FThabet

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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