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Efficacy of Thymosin alpha1 for Severe Sepsis (ETASS)

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Severe Sepsis

Treatments

Drug: Thymosin alpha 1

Study type

Interventional

Funder types

Other

Identifiers

NCT00711620
2007015

Details and patient eligibility

About

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

Full 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.

Enrollment

366 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

366 participants in 2 patient groups, including a placebo group

Thymosin alpha 1+Standard Therapy
Experimental group
Description:
Patients receive treatment based on SSC guideline with additional thymosin alpha1
Treatment:
Drug: Thymosin alpha 1
normal saline+standard therapy
Placebo Comparator group
Description:
Patients receive treatment based on SSC guideline with additional normal saline.
Treatment:
Drug: Thymosin alpha 1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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