A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 466
- 试验地点
- 83
研究概览
简要总结
The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins.
The study drug is an investigational drug that is still in development. It has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. Patient participation in this study will last for about one month.
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
- Double
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
- •Patients must
- •show evidence of acute infection
- •meet specified time windows
- •be 18 years of age or older
排除标准
- •Patients must not
- •have low white blood cell count
- •have undergone certain organ transplants
- •be HIV positive
- •be pregnant or breast feeding
- •have severe underlying medical problems