Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia: The COLIPED Investigation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Incidence of Ventilation Associated Pneumonia
研究概览
简要总结
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.
详细描述
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%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children older than 1 month and younger than 14 years
- •Patients on invasive mechanical ventilation for more than 48 hours
- •Informed parental consent
排除标准
- •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
研究组 & 干预措施
colistin group
Colistin group:
In the Nebulized colistimethate sodium (CMS) group, 100 000 IU/kg of CMS (equivalent to 0.96 mg/kg of colistin base), will be nebulized daily, divided into two doses. The lyophilisate of CMS will be reconstituted as follows: 2 million of IU is reconstituted in 6mL of sterile 0.9% saline. The adequate volume is then withdrawn and compleated by 0.9% saline to reach a total volume of 6 ml that is administered immediately to mechanically ventilated patients via a nebulizer until the nebulized solution container becomes empty.
The nebulization is administered from day 3 of invasive mechanical ventilation, twice daily for a maximum of 7 days or until extubation (whichever occurres first).
*12500 International Units of colistimethate sodium = 1 mg colistimethate sodium = 0.4 mg of colistin base.
干预措施: colistimethate sodium (Drug)
Control group
Nebulization of 6 ml of 0.9% saline twice a day for a maximum of 7 days from day 3 of invasive mechanical ventilation will be administered via a nebulizer until the nebulized solution container becomes empty.
干预措施: 0.9% Saline (Drug)
结局指标
主要结局
Incidence of Ventilation Associated Pneumonia
时间窗: 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
次要结局
- Incidence of Ventilation Associated Tracheobronchitis(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(From randomization to 28 days post-randomization)
- Number of days spent on mechanical ventilation from randomization to day 28(From randomization to 28 days post-randomization)
- Number of days without systemic antibiotics from randomization to day 28(From randomization to 28 days post-randomization)
- ICU stay(From randomization to ICU discharge, up to 60 days)
- Incidence of antibiotic-resistant bacteria(From randomization to ICU discharge)
- ICU day-28 mortality(28 days from ICU admission)
研究者
Farah Thabet
PROFESSOR IN PEDIATRICS
University of Monastir