Efficacy of Thymosin alpha1 for Severe Sepsis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.

Detailed Description
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Severe sepsis is a disease of infectious origin with a high risk of death. Over the past decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight against infectious diseases, but it is unknown whether thymosin alpha1 is effective in treating severe sepsis.

Official Title
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Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis

Conditions
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Severe Sepsis

Intervention / Treatment
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* Drug: Thymosin alpha 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe sepsis according to ACCP/CCM criteria Patient or legally authorized representative able to provide informed consent Exclusion Criteria: Subject is less than 18 years or more than 85 years of age If female, the subject is pregnant or nursing Subject is receiving immunosuppressive therapy such as cyclosporine, azothioprine,or cancer-related chemotherapy Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end-stage disease History of bone marrow, lung, liver, pancreas, or small-bowel transplantation Acute pancreatitis with no established source of infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymosin alpha 1+Standard Therapy<br>Patients receive treatment based on SSC guideline with additional thymosin alpha1 | Drug: Thymosin alpha 1<br>* 1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days.<br>* Other names: Zadaxin;|
| Placebo Comparator: normal saline+standard therapy<br>Patients receive treatment based on SSC guideline with additional normal saline. | Drug: Thymosin alpha 1<br>* 1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days.<br>* Other names: Zadaxin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day Mortality | The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA score | SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups. | 7 days | 
| Immune response to Thymosin alpha 1 | HLA-DR expression on CD14+,ratio between CD4+ and CD8+, CRP on day 0, 3, 7 after the start of the infusion in both groups. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, Immunotherapy, Thymosin