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Completed

NCT Number: NCT00711620

Efficacy of Thymosin alpha1 for Severe Sepsis

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

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymosin alpha 1

Drug

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

Primary outcomes

  1. 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

  1. SOFA score

    Time frame: 7 days

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

  2. 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: ETASS

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jul 9, 2008
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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