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NCT00711620·Not applicable·INTERVENTIONAL

Efficacy of Thymosin alpha1 for Severe Sepsis

Thymosin Alpha-1InflammationCompleted

Status

Completed

Phase

Not applicable

Enrollment

366

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jul 9, 2008

  2. Study start

    May 2008

  3. Primary completion

    Dec 2010

  4. Study completion

    Jan 2011

  5. Results posted

    Not reported

  6. Registry updated

    Jun 14, 2011

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

SOFA score

Time frame · 7 days

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

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Sun Yat-sen University

Guangzhou, Guangdong, China

Publications

Results and literature.

PMID 23327199 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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