NCT02867267已完成3 期
The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial
Sun Yat-sen University22 个研究点 分布在 1 个国家目标入组 1,106 人开始时间: 2016年9月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,106
- 试验地点
- 22
- 主要终点
- 28-day all-cause mortality
研究概览
简要总结
The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis
详细描述
Our previous study reported that the 7-day treatment of Ta 1 demonstrated positive active effect as to the 28-day all-cause mortality and the augmentation of mHLA-DR (monocyte Human Leukocyte Antigen DR) at the secondary endpoint. Therefore, we intend to verify this finding through a randomized, double-blind and placebo-controlled clinical trial and the trail will include subjects with impaired immunologic functions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤85;
- •Signed informed consent signed;
- •Diagnosed as a sepsis according to the sepsis diagnosis criteria in "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016": at least one acute severe organ dysfunction related to sepsis, and total SOFA scores ≥2;
- •Infected focus are confirmed or suspected and satisfy at least one of the followings:
- •pathogenic microbes grow in blood or at aseptic locations
- •presence of abscess or partially-infected tissues
- •suspected infection identified by at least one of the following evidences:
- •leukocytes at normal aseptic locations
- •organic perforation (confirmed by imaging evidence, examination result or intestinal content leak during drainage)
- •Imaging evidence of pneumonia accompanied by purulent secretion
- •Related syndromes with high infection risk (cholangitis for example)
排除标准
- •History of organ or bone marrow transplantation;
- •Acute phase connective tissue diseases (such as rheumatoid diseases, systemic lupus erythematosus) and glomerulonephritis;
- •Under pregnancy or in suckling period;
- •Presence of hematologic malignancies;
- •The patient has received radiotherapy or chemotherapy within the past 30 days;
- •The patient is inclined to stop or cancel the artificial intervention for sustaining life, in other words, has abandoned treatment;
- •The patient has in the past 30 days received immunosuppressive drugs (tripterygium wilfordii, CellCept, cyclophosphamide, FK506, etc.) or received continuous treatment with prednisolone >10 mg/day (or the same dose of other hormones);
- •The patient could die of an underlying disease within 28 days or is in end-stage;
- •The patient has undergone CPR in the 72 hours before signing the informed consent and the neuromechanism has not fully recovered (GCS score ≤ 8);
- •The patient has in the past 30 days used thymosin or undergone certain clinical drug or instrument trials which could affect immunity (such as Xuebijing, ulinastatin and CRRT);
- •The patient has a medical history of allergy or intolerance to thymalfasin;
- •The source of infection cannot be contained, for example: infections that cannot be handled during surgical operations and drainage.
研究组 & 干预措施
thymosin alpha 1
Experimental
1ml subcutaneous injection with 1.6 mg thymosin alpha 1, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition
干预措施: Thymosin alpha 1 (Drug)
Placebo
Placebo Comparator
1ml subcutaneous injection with placebo, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition
干预措施: Placebo (Other)
结局指标
主要结局
28-day all-cause mortality
时间窗: 28 days
次要结局
- ICU-free days within 28 days(28 days)
- Vasoactive agents-free days within 28 days(28 days)
- ICU stays(90 days)
- Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28(28 days)
- Variance of the count of monocyte human lymphocyte antigens-DR (mHLA-DR) at days 7, 14 and 28 compared with the baseline at screening(28 days)
- 28-day re-hospitalization rate(28 days)
- ICU mortality(90 days)
- Ventilator-free days within 28 days(28 days)
- 90-day SF-36 QOL scale(90 days)
- Incidence of new onset infection within 28 days(28 days)
- 28-day clearance rate of pathogenic microorganism(28 days)
- Hospital stays(28 days)
- The percentage of Treg cells at screening and days 7(7 days)
- 90-day all-cause mortality(90 days)
- CRRT-free days within 28 days(28 days)
研究者
Wu Jianfeng
Clinical Professor
Sun Yat-sen University
研究点 (22)
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