Phase 3b Randomized Double Blind Controled Placebo Comparative Trial of Intravenous Colistin vs Intravenous Colistin Plus Nebulized Colistin in Patients With Ventilator-associated Pneumonia (VAP) Due Multiresistant Acinetobacter Baumanii
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant
研究概览
简要总结
Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.
详细描述
Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose of VAP due A. baumannii or A. baumannii and another microorganism carbapenems resistant.
- •Clinical Pulmonary Infection Score (CPIS) > 6
排除标准
- •Allergy to colistin.
- •Shock status
- •Diagnose of VAP due A. baumannii colistin resistant.
研究组 & 干预措施
A
Intravenous colistin and nebulized colistin
干预措施: Colistin (Drug)
B
intravenous colistin and saline solution nebulized
干预措施: Colistin and saline solution (Drug)
结局指标
主要结局
Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant
时间窗: 14 days
次要结局
未报告次要终点