Efficacy of Thymosin alpha1 for Severe Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Severe Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Thymosin alpha 1+Standard Therapy

Patients receive treatment based on SSC guideline with additional thymosin alpha1

Group Type EXPERIMENTAL

Thymosin alpha 1

Intervention Type 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.

normal saline+standard therapy

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

Group Type PLACEBO_COMPARATOR

Thymosin alpha 1

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Zadaxin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No