Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Clinical pulmonary infection score
研究概览
简要总结
The purpose of this study was to determine the effect of aerosolized colistin on to ventilated patients with carbapenem-resistant gram negative bacteria pneumonia. We hypothesize that adjunct aerosolized colistin, which achieve high drug concentrations in the airway, would more effectively treat the penumbra.
详细描述
To treat respiratory infection of patients with mechanical ventilation, greater systemic antibiotic dose is required through the patient's venous injection. In this trial, patients with arbapenem-resistant gram negative bacteria pneumonia (CRGNB)were assigned to adjunct aerosolized colistin delivered by a jet nebulizer or a vibrating mesh nebulizer comparing to or standard intravenous injection by a randomizing protocol.
Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between standard care and study drug for their effects on bacteria eradiation, incidence of nephrotoxicity, and oxygenation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received invasive mechanical ventilation >48 hours
- •Diagnosed with pneumonia caused by carbapenem resistance gram negative bacteria
排除标准
- •pregnant or lactating women
- •receiving colistin > 3 days
- •recurrent pneumonia caused by carbapenem resistance gram negative bacteria
- •allergy to colistin or polymyxin B drugs
- •immunocompromised, defined as neutropenia ANC<500 cells/ul
- •HIV positive
- •received chemotherapy with 3 months
- •renal function deficiency (creatinine clearance < 30 ml/min)
结局指标
主要结局
Clinical pulmonary infection score
时间窗: 7-10 days
The clinical pulmonary infection score calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation impairment
次要结局
- Ventilator pressure control level(7-10 days)
研究者
Hui-Ling Lin
Associate professor
Chang Gung University