EUCTR2016-001054-17-FR进行中（未招募）1 期
Double-blinded multicenter randomized controlled trial comparing inhaled amikacin versus placebo to prevent ventilator associated pneumonia - AMIKINHA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age = 18 years the day of inclusion
- •- Mechanical ventilation through an endotracheal tube for more than three consecutive days (72h)
- •- Written informed consent of the patient or a proxy
- •- Patients covered by or having the rights to French social security
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •- Suspicion or confirmed VAP
- •- Clinical indication for systemic aminoglycoside therapy
- •- Stage 3 KDIGO classification acute kidney injury excepted in patients undergoing renal replacement therapy
- •- Patient scheduled for extubation within the next 24h
- •- Patient ventilated more than 4 days before inclusion (96h)
- •- Patient ventilated through a tracheostomy
- •- Patients allergic to aminoglycosides
- •- Myasthenia gravis
- •- Pregnant or lactating patients
- •- Patients undergoing guardianship or trusteeship
- •- Patients previously included in this study
研究者
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