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Trial · Interventional

CompletedNot applicableRegistry data

Efficacy of Thymosin alpha1 for Severe Sepsis

Short name ETASS

NCTNCT00711620 (opens ClinicalTrials.gov in a new tab)Other id2007015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
366 participants (actual)
Sponsor
Sun Yat-sen University · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
May 2008
Primary completion
Dec 2010
Completion
Jan 2011
First posted
9 Jul 2008 (estimated)
Last update posted
14 Jun 2011 (estimated)
Conditions
Severe Sepsis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009201020112012
  1. N/A

    ETASS

    NCT00711620

    May 2008 to Jan 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Thymosin alpha 1Drug

Arms2

  • Experimental

    Thymosin alpha 1+Standard Therapy

    Patients receive treatment based on SSC guideline with additional thymosin alpha1

  • Placebo comparator

    normal saline+standard therapy

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 28-day Mortality

    Time frame · 28 days

    Registry description

    The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion.

Secondary outcomes(2)

  1. SOFA score

    Time frame · 7 days

    Registry description

    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

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

4 results

The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial.

Wu et al. 2013Critical care (London, England)cited by 105

PMID 23327199PMC4056079DOI 10.1186/cc11932PUB-23327199

CC BY4 results
Download PDFSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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