NCT00568737已完成3 期
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,640
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
Adult Patients with Severe Sepsis
详细描述
Compared with placebo, drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with severe sepsis at low risk of death (for example, with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score <25 or single organ dysfunction).
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 (Participant, Investigator)
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
- •Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.
排除标准
- •Are indicated for the treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
- •Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
- •Platelet count less than 30,000/mm3.
研究组 & 干预措施
1
Experimental
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
干预措施: Drotrecogin alfa (activated) (Drug)
2
Placebo Comparator
0.9% sodium chloride
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy
时间窗: 20 months
次要结局
- Safety(20 months)
研究者
研究点 (1)
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