NCT01297855Unknown3 期
Randomized Controlled Trial of Colistin Versus Colistin Plus Rifampicin in MDR P.Aeruginosa and A.Baumanii
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- number of subjects with cure or improvement
研究概览
简要总结
In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.
In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to receive Colistin alone and another group will receive Colistin plus Rifampicin.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •Hospitalized to Siriraj Hospital
- •Infection with MDR A.baumanii or P.aeruginosa
- •Nescessary for treatment with Colistin
- •Patient agrees to participate by giving written informed consent.
排除标准
- •pregnancy or lactating mother
- •Colistin or Rifampicin allergy
- •Active hepatic disease or abnormal liver function test
- •patient who suspected infection with mycobacterium tuberculosis
- •patient who can not drug by enteral feeding
研究组 & 干预措施
Colistin
Active Comparator
Colistate
干预措施: Colistin (Drug)
Colistin plus Rifampicin
Experimental
Colistate Rifampin
干预措施: Colistin plus Rifampicin (Drug)
结局指标
主要结局
number of subjects with cure or improvement
时间窗: up to day 28
Cure Improvement Worse Death
次要结局
- number of subjects with eradication of causative bacteria(up to day 28)
研究者
Visanu Thamlikitkul
Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
Mahidol University
研究点 (1)
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