Efficacy of Thymosin alpha1 for Severe Sepsis - Full Text View

Sponsored by:	Sun Yat-sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00711620

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

MedlinePlus related topics: Sepsis

Drug Information available for: Thymalfasin

U.S. FDA Resources

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

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 ]

Secondary Outcome Measures:

SOFA score during intensive care unit length of stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Immune response to Thymosin alpha 1 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	334
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.
B: No Intervention Patients receive treatment based on SSC guideline.

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 80 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 80 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

Contacts

Contact: Guan Xiangdong, M.D	020-87755766 ext 8456	carlg@163.com
Contact: Wu Jianfeng, M.D	020-87755766 ext 8454	wujianfeng9571@163.com

Locations

China, Guangdong
Sun Yat-sen University	Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wu Jianfeng, M.D 020-87755766 ext 8454 wujiafeng9571@163.com
Contact: Guan Xiangdong, M.D 020-87755766 ext 8456 carlg@163.com
Principal Investigator: Guan Xiangdong, M.D
Sub-Investigator: Wu Jianfeng, M.D

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:	Sun Yat-sen University ( Guan Xiangdong )
Study ID Numbers:	2007015
Study First Received:	June 27, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00711620 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Sun Yat-sen University:

sepsis
Immunotherapy
Thymosin

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Thymalfasin

Immunologic Factors
Adjuvants, Immunologic
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Sepsis
Thymalfasin
Pathologic Processes
Immunologic Factors
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009