Sepsis
Conditions
Keywords
thymosin alpha 1; thymalfasin; sepsis; immunodepression
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.
Interventions
DRUGThymosin 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.
OTHERPlacebo
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.
Sponsors
SciClone Pharmaceuticals
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28 | 28 days | — |
| 90-day all-cause mortality | 90 days | — |
| ICU mortality | 90 days | — |
| Ventilator-free days within 28 days | 28 days | — |
| ICU-free days within 28 days | 28 days | — |
| CRRT-free days within 28 days | 28 days | — |
| 28-day re-hospitalization rate | 28 days | — |
| Incidence of new onset infection within 28 days | 28 days | from initial injection on day 0 to day 28 |
| 28-day clearance rate of pathogenic microorganism | 28 days | — |
| ICU stays | 90 days | — |
| Hospital stays | 28 days | — |
| Vasoactive agents-free days within 28 days | 28 days | — |
| 90-day SF-36 QOL scale | 90 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 | — |
| The percentage of Treg cells at screening and days 7 | 7 days | — |
Countries
China
Outcome results
None listed