Nebulized amikacin versus placebo for the prevention of ventilator associated pneumonia: A double-blind randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- To study the effect of prophylactic nebulization with Amikacin on the ventilator associated pneumonia rate in mechanically ventilated children 1 month to 15 years of age admitted to the PICU till day-28 post randomisation.
研究概览
简要总结
Ventilator associated pneumonia (VAP) is one of the most common health-care associated infections in the world, and is associated with significant mortality and morbidity. The present management of VAP predominantly involved incorporation of care bundles for its prevention. There exists literature based on studies in adults which propose that prophylactic administration of of inhaled antibiotics, especially Aminoglycosides, may have a beneficial role in the prevention of VAP. However, no randomised controlled trials have been conducted to assess the efficacy of Inhaled Aminoglycosides in the prevention of VAP in children.
The study aims to enrol 184 ventilated children in 2 arms (Amikacin nebulization and Placebo nebulization, 92 patients in each arm) from the time of approval till July 2026 and nebulize them with the allotted intervention for a period of 3 days.
The primary objective of the study will be to determine the incidence of VAP in children in the 2 arms, with secondary objectives including PICU length of stay, mortality, emergence of drug resistant strains (on BAL cultures), incidence of ventilator-associated events (VAE) and various other parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •All children between the age of 1 month to 15 years admitted in the PICU with a duration of mechanical ventilation of not more than 96 hours.
排除标准
- •Patients with contraindications to the disconnection of the ventilator circuit due to the underlying disease process.
- •Microbiologically confirmed VAP on the day of inclusion.
- •Patient scheduled for extubation in the next 24 hours.
- •Patient ventilated through an endotracheal tube for more than 4 consecutive days before inclusion (96 hours).
- •Patients ventilated through tracheostomy.
- •Patients allergic to aminoglycosides.
结局指标
主要结局
To study the effect of prophylactic nebulization with Amikacin on the ventilator associated pneumonia rate in mechanically ventilated children 1 month to 15 years of age admitted to the PICU till day-28 post randomisation.
时间窗: To study the effect of prophylactic nebulization with Amikacin on the ventilator associated pneumonia rate in mechanically ventilated children 1 month to 15 years of age admitted to the PICU till day-28 post randomisation.
次要结局
- To study the effect of prophylactic nebulization with Amikacin in mechanically ventilated children between 1 month to 15 years of age admitted to the PICU on length of stay in the PICU(28 days)
- To study the effect of prophylactic nebulization with Amikacin in mechanically ventilated children between 1 month to 15 years of age admitted to the PICU on Mortality(28 days)
研究者
Arjun Kurup
All India Institute of Medical Sciences