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Efficacy of Thymosin alpha1 for Severe Sepsis (ETASS)

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00711620
First received: June 27, 2008
Last updated: June 13, 2011
Last verified: October 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

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

Primary Outcome Measures:
  • 28-day Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711620

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

No publications provided

Responsible Party: Guan Xiangdong, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00711620     History of Changes
Other Study ID Numbers: 2007015
Study First Received: June 27, 2008
Last Updated: June 13, 2011
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
sepsis
Immunotherapy
Thymosin

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Thymalfasin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013