Efficacy of Thymosin alpha1 for Severe Sepsis
ETASS
Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis
1 other identifier
interventional
366
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJune 14, 2011
October 1, 2009
2.6 years
June 27, 2008
June 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
SOFA score
7 days
Immune response to Thymosin alpha 1
7 days
Study Arms (2)
Thymosin alpha 1+Standard Therapy
EXPERIMENTALPatients receive treatment based on SSC guideline with additional thymosin alpha1
normal saline+standard therapy
PLACEBO COMPARATORPatients receive treatment based on SSC guideline with additional normal saline.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Severe sepsis according to ACCP/CCM criteria
- Patient or legally authorized representative able to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Related Publications (1)
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.
PMID: 23327199DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guan Xiangdong, M.D
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 9, 2008
Study Start
May 1, 2008
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
June 14, 2011
Record last verified: 2009-10