Randomized, Double bind, Two arm, Multicentric, Comparative Controlled ,Prospective Clinical trial of Mycobacterium w in combination with satandard therapy versus standard therapy alone in sepsis due to gram(-)ve infections.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To determine the mortality at different dose levels in comparision to standard therapy.
研究概览
简要总结
This study is a randomized double blind, two arms, multicentric, comparative controlled prospective clinical trial of mycobacterium w in combination with standard therapy versus standard therapy alone in sepsis due to gram (-) infections for six month (28 days in each groups) in 72 patients (devide into three groups) that will be conducted in three centers. The primary outcome to determine the 28 days mortality at different dose levels in comparisions to standard therapy. The secondary outcome to observe effacts on organ function and to assess safety and tolerability by determinig the incidence of adverse events in the treatment groups versus control and to observe the effects on serum IL-6,IL-8,TNF-alpha,C3B and CRP levls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults of either gender with both margins inclusive(18-65 years) with a diagnosis of Severe systemic gram negative sepsis or septic shock.
排除标准
- •Patients with history of allergy,hypersensitivity, or any serious reaction to Mycobacterium w.
- •and with a concomitant medical condition,which may create an unacceptable additional risks.
结局指标
主要结局
To determine the mortality at different dose levels in comparision to standard therapy.
时间窗: 28 days
次要结局
- Effects on organ function(28 days)
- Assess safety/tolerability by detyerminig the incidence of adverse events in the treatments group versus control(28 days)
- Effects on serum IL-6,IL-8, TNF-alpha,C3B and CRP levels(28 days)