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Efficacy of Thymosin alpha1 for Severe Sepsis (ETASS)

This study has been completed.
Information provided by:
Sun Yat-sen University Identifier:
First received: June 27, 2008
Last updated: June 13, 2011
Last verified: October 2009
The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.

Condition Intervention
Severe Sepsis
Drug: Thymosin alpha 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis

Resource links provided by NLM:

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 28-day Mortality [ Time Frame: 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:
  • SOFA score [ Time Frame: 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 [ Time Frame: 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.

Enrollment: 366
Study Start Date: May 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thymosin alpha 1+Standard Therapy
Patients receive treatment based on SSC guideline with additional thymosin alpha1
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.
Other Name: Zadaxin
Placebo Comparator: normal saline+standard therapy
Patients receive treatment based on SSC guideline with additional normal saline.
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.
Other Name: Zadaxin

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00711620

China, Guangdong
Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Study Chair: Guan Xiangdong, M.D Sun Yat-sen University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Guan Xiangdong, Sun Yat-sen University Identifier: NCT00711620     History of Changes
Other Study ID Numbers: 2007015
Study First Received: June 27, 2008
Last Updated: June 13, 2011

Keywords provided by Sun Yat-sen University:

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents processed this record on May 25, 2017