NCT00136201已完成3 期
A Multicenter, Randomized, Open-Label Comparison of the Safety and Efficacy of Tigecycline> vs Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Chinese Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 200 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit
研究概览
简要总结
The primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated intra-abdominal infections. <br />
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •· Hospitalized male or female subjects over 18 years of age
排除标准
- •· Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.
研究组 & 干预措施
1
Experimental
armDesc1
干预措施: tigecycline (Drug)
结局指标
主要结局
Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit
次要结局
- Microbiological response at the subject and pathogen level and evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and minimal inhibitory concentration (MIC) values and susceptibility data by isolate
研究者
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