CTRI/2024/01/061600尚未招募Unknown
Study of Inj. Sepsivac® in gram negative sepsis
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 28 days all-cause mortality
研究概览
简要总结
Based on the efficacy and safety data of Mycobacterium w (Mw) as observed in previous clinical studies, we hypothesize that using Mw as adjuvant to standard treatment in sepsis via intravenous route will be safe as well as effective in decreasing complications, hasten the organ function recovery and reduce the 28 day mortality associated with sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Presumed or Suspected or Confirmed Sepsis due to gram negative infection.
排除标准
- •â€¢ History of allergic reactions attributed to Inj.
- •Sepsivac® or any of its excipients • Pregnant and lactating women.
结局指标
主要结局
28 days all-cause mortality
时间窗: Day 1, 2, 3, 4, 7, 14, 28
次要结局
- 1. Change in clinical and laboratory parameters(2. Change in SOFA score)
研究者
Dr Madhusudhan Jaju
Yashoda Hospital
研究点 (1)
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