NCT00619710已完成3 期
A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.
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
- Pfizer
- 入组人数
- 1,000
- 主要终点
- The primary measure is clinical response after all antibacterial treatment is stopped).
研究概览
简要总结
The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections
- •Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing
- •Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection
排除标准
- •Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems
- •Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication
- •Subjects with underlying infections or conditions which would interfere with evaluation of this study
研究组 & 干预措施
1
Experimental
Meropenem
干预措施: Meropenem (Drug)
2
Active Comparator
Imipenem-cilastatin
干预措施: Imipenem-cilastatin (Drug)
结局指标
主要结局
The primary measure is clinical response after all antibacterial treatment is stopped).
时间窗: 7-28 days
次要结局
- clinical and microbiological response(Twice 3-28 days)
研究者
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