Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02867267
Other study ID # ZDX-2015-11
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 6, 2016
Est. completion date March 23, 2021

Study information

Verified date April 2023
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis


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 information / eligibility

Status Completed
Enrollment 1106
Est. completion date March 23, 2021
Est. primary completion date January 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Age = 18 and =85; 2. Signed informed consent signed; 3. 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; 4. Infected focus are confirmed or suspected and satisfy at least one of the followings: 1. pathogenic microbes grow in blood or at aseptic locations 2. presence of abscess or partially-infected tissues 3. 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) Exclusion Criteria: 1. History of organ or bone marrow transplantation; 2. Acute phase connective tissue diseases (such as rheumatoid diseases, systemic lupus erythematosus) and glomerulonephritis; 3. Under pregnancy or in suckling period; 4. Presence of hematologic malignancies; 5. The patient has received radiotherapy or chemotherapy within the past 30 days; 6. The patient is inclined to stop or cancel the artificial intervention for sustaining life, in other words, has abandoned treatment; 7. 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); 8. The patient could die of an underlying disease within 28 days or is in end-stage; 9. The patient has undergone CPR in the 72 hours before signing the informed consent and the neuromechanism has not fully recovered (GCS score = 8); 10. 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); 11. The patient has a medical history of allergy or intolerance to thymalfasin; 12. The source of infection cannot be contained, for example: infections that cannot be handled during surgical operations and drainage.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Thymosin alpha 1
Subcutaneous injections of 1.6 mg thymosin alpha 1 every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
Other:
Placebo
Subcutaneous injections of placebo every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.

Locations

Country Name City State
China Beijing Friendship Hospital, Capital Medical University Beijing
China Chinese PLA General Hospital Beijing Beijing
China Peking Union Medical College Hospital Beijing Beijing
China West China Hospital, Sichuan University Chengdu Sichuan
China The First People's Hospital of Foshan Foshan Guangdong
China Guangzhou First People's Hospital Guangzhou Guangdong
China Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou Guangdong
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China The Sixth Affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong
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 Shandong Provincial Hospital Jinan Shandong
China Nanjing General Hospital of Nanjing Military Commend Nanjing Jiangsu
China Qingyuan People's Hospital Qingyuan Guangdong
China Shanghai Ruijin Hospital Shanghai Shanghai
China Shanghai Zhongshan Hospital, Fudan University Shanghai Shanghai
China Peking University Shenzhen Hospital Shenzhen Guangdong
China Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
China The First Affiliated Hospital of Xi 'an Jiaotong University Xi'an Shaanxi
China Zhuhai People's Hospital Zhuhai Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University SciClone Pharmaceuticals

Country where clinical trial is conducted

China, 

References & Publications (4)

Romani L, Bistoni F, Montagnoli C, Gaziano R, Bozza S, Bonifazi P, Zelante T, Moretti S, Rasi G, Garaci E, Puccetti P. Thymosin alpha1: an endogenous regulator of inflammation, immunity, and tolerance. Ann N Y Acad Sci. 2007 Sep;1112:326-38. doi: 10.1196/ — View Citation

Romani L, Moretti S, Fallarino F, Bozza S, Ruggeri L, Casagrande A, Aversa F, Bistoni F, Velardi A, Garaci E. Jack of all trades: thymosin alpha1 and its pleiotropy. Ann N Y Acad Sci. 2012 Oct;1269:1-6. doi: 10.1111/j.1749-6632.2012.06716.x. — View Citation

Wang X, Li W, Niu C, Pan L, Li N, Li J. Thymosin alpha 1 is associated with improved cellular immunity and reduced infection rate in severe acute pancreatitis patients in a double-blind randomized control study. Inflammation. 2011 Jun;34(3):198-202. doi: — View Citation

Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 28-day all-cause mortality 28 days
Secondary Incidence of new onset infection within 28 days from initial injection on day 0 to day 28 28 days
Secondary 28-day clearance rate of pathogenic microorganism 28 days
Secondary ICU stays 90 days
Secondary Hospital stays 28 days
Secondary 28-day re-hospitalization rate 28 days
Secondary Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28 28 days
Secondary 90-day all-cause mortality 90 days
Secondary ICU mortality 90 days
Secondary Ventilator-free days within 28 days 28 days
Secondary ICU-free days within 28 days 28 days
Secondary CRRT-free days within 28 days 28 days
Secondary Vasoactive agents-free days within 28 days 28 days
Secondary 90-day SF-36 QOL scale 90 days
Secondary 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
Secondary The percentage of Treg cells at screening and days 7 7 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A