NCT02330432已完成2 期
Phase IIb Randomized, Double Blind, Two Arm, Controlled Clinical Trial of Mycobacterium W in Combination With Standard Therapy Versus Standard Therapy Alone in Sepsis
Post Graduate Institute of Medical Education and Research, Chandigarh2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in restoring immunity, thereby improving outcomes in patients with severe sepsis.
In this randomized trial, the investigators propose to evaluate the efficacy of Mw in patients with severe sepsis.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe sepsis within 48 hours of first organ dysfunction
- •Cardiovascular system dysfunction: systolic blood pressure ≤90 mm Hg or the mean arterial pressure ≤70 mm Hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of >90 and >65 mm Hg, respectively
- •Renal dysfunction: urine output <0.5 ml/kg/hour for two consecutive hours despite adequate fluid resuscitation
- •Respiratory system dysfunction: PaO2/FiO2 ≤300 or ≤250 if lung sepsis
- •Hematologic dysfunction: platelet count <100,000/mm3 or decrease by 50% in the three days preceding enrollment
- •Unexplained metabolic acidosis: pH ≤7.30
排除标准
- •Pregnancy
- •Gram-positive culture
- •Only fungal infection as source of sepsis
- •Patients who received cardiopulmonary resuscitation
- •Those on immunosuppressive therapy
- •Those unwilling to provide informed consent
结局指标
主要结局
Mortality
时间窗: 28-day
28-day all-cause mortality
次要结局
- New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA)(28-day)
- Hospital length of stay(28-day)
- New-onset infection(28-day)
- ICU length of stay(28-day)
- Time-to-vasopressor withdrawal(28-day)
- Ventilator-free days(28-day)
研究者
Ritesh Agarwal
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh
研究点 (2)
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