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Efficacy of Thymosin alpha1 for Severe Sepsis (ETASS)

Primary Purpose

Severe Sepsis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thymosin alpha 1
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring sepsis, Immunotherapy, Thymosin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thymosin alpha 1+Standard Therapy

normal saline+standard therapy

Arm Description

Patients receive treatment based on SSC guideline with additional thymosin alpha1

Patients receive treatment based on SSC guideline with additional normal saline.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

SOFA score
SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups.
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.

Full Information

First Posted
June 27, 2008
Last Updated
June 13, 2011
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00711620
Brief Title
Efficacy of Thymosin alpha1 for Severe Sepsis
Acronym
ETASS
Official Title
Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
sepsis, Immunotherapy, Thymosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thymosin alpha 1+Standard Therapy
Arm Type
Experimental
Arm Description
Patients receive treatment based on SSC guideline with additional thymosin alpha1
Arm Title
normal saline+standard therapy
Arm Type
Placebo Comparator
Arm Description
Patients receive treatment based on SSC guideline with additional normal saline.
Intervention Type
Drug
Intervention Name(s)
Thymosin alpha 1
Other Intervention Name(s)
Zadaxin
Intervention Description
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.
Primary Outcome Measure Information:
Title
28-day Mortality
Description
The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
SOFA score
Description
SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups.
Time Frame
7 days
Title
Immune response to Thymosin alpha 1
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guan Xiangdong, M.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23327199
Citation
Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
Results Reference
derived

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Efficacy of Thymosin alpha1 for Severe Sepsis

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