Efficacy of Thymosin alpha1 for Severe Sepsis

Severe Sepsis Clinical Trial

— ETASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711620
• Other study ID #: 2007015
• Status: Completed
• Phase: N/A
• First received: June 27, 2008
• Last updated: June 13, 2011
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: October 2009
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

Drug:
• Thymosin alpha 1
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	SOFA score	SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups.	7 days	No
Secondary	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	No