The Efficacy and Safety of Ta1 for Sepsis
- Registration Number
- NCT02867267
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1106
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Age ≥ 18 and ≤85;
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Signed informed consent signed;
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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;
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Infected focus are confirmed or suspected and satisfy at least one of the followings:
-
pathogenic microbes grow in blood or at aseptic locations
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presence of abscess or partially-infected tissues
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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)
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- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 1ml subcutaneous injection with placebo, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition thymosin alpha 1 Thymosin alpha 1 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
- Primary Outcome Measures
Name Time Method 28-day all-cause mortality 28 days
- Secondary Outcome Measures
Name Time Method 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 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 Incidence of new onset infection within 28 days 28 days from initial injection on day 0 to day 28
90-day all-cause mortality 90 days CRRT-free days within 28 days 28 days
Trial Locations
- Locations (22)
Shanghai Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
The First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Qingyuan People's Hospital
🇨🇳Qingyuan, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Xi 'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Zhuhai People's Hospital
🇨🇳Zhuhai, Guangdong, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Nanjing General Hospital of Nanjing Military Commend
🇨🇳Nanjing, Jiangsu, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Shanghai Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China