Efficacy of Thymosin alpha1 for Severe Sepsis (ETASS)

June 13, 2011 updated by: Sun Yat-sen University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Zadaxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOFA score
Time Frame: 7 days
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
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Guan Xiangdong, M.D, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Sepsis

Clinical Trials on Thymosin alpha 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe