NCT00318552已完成4 期
Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 160
- 试验地点
- 13
- 主要终点
- Number of days from randomization to recovery from sepsis among those patients who survived the trial period
研究概览
简要总结
This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.
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
- •Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.
排除标准
- 未提供
结局指标
主要结局
Number of days from randomization to recovery from sepsis among those patients who survived the trial period
Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis
次要结局
- Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy
- Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials
- Number of days on first line antibiotic therapy
- Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy
- Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group
- Number of days from randomization to ready to discharge from the ICU
- Number of days from randomization until patient is discharged from the ICU
- Number of days from randomization until patient is discharged from hospital
- Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group
研究者
研究点 (13)
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