Efficacy of Thymosin alpha1 for Severe Sepsis

Not Applicable

Completed

• Conditions: Severe Sepsis
• Interventions: Drug: Thymosin alpha 1

• Registration Number: NCT00711620
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-09
• Status Verified: 2009-10
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Last Update Submitted: 2011-06-13
• Last Update Posted: 2011-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thymosin alpha 1+Standard Therapy	Thymosin alpha 1	Patients receive treatment based on SSC guideline with additional thymosin alpha1
normal saline+standard therapy	Thymosin alpha 1	Patients receive treatment based on SSC guideline with additional normal saline.

Primary Outcome Measures

Name	Time	Method
28-day Mortality	28 days	The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion.

Secondary Outcome Measures

Name	Time	Method
SOFA score	7 days	SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups.
Immune response to Thymosin alpha 1	7 days	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.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China