Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
试验速览
- 阶段
- 3 期
- 入组人数
- 62
- 主要终点
- Number of Patients With Cure, Improved, Failure or Death
研究概览
简要总结
The purpose of this study is to determine whether inhaled colistin is effective in the treatment of ventilator associated tracheobronchitis due to gram negative organism susceptible to colistin.
详细描述
Patients diagnosed ventilator-associated tracheobronchitis due to gram negative organism are included to the study.The patients will be received colistin inhalation 75 mg every 12 hours at least 5 days.
The primary objective is to evaluate clinical outcome of inhaled colistin. The secondary objectives are microbiological clearance and toxicity of inhaled colistin.
The sample size was estimated to 62 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of ventilator-associated tracheobronchitis caused by gram negative organism.
- •Expected to survive more than 48 hours after enrollment.
- •Received intravenous colistin not more than 48 hours prior enrollment.
排除标准
- •Pregnancy and Lactation
- •Allergy to colistin
- •Serum creatinine > 4 mg/dl or GFR decreased more than 75% from baseline
研究组 & 干预措施
inhaled colistin
Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days
干预措施: Inhaled colistin (Drug)
结局指标
主要结局
Number of Patients With Cure, Improved, Failure or Death
时间窗: through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure Improved Failure Death
次要结局
- Number of Patients With Eradication, Persistence or Superinfection(through study completion, an average of 2 weeks)
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0(through study completion, an average of 2 weeks)
研究者
Adhiratha Boonyasiri
Dr.
Mahidol University