Long-term Prognosis of Patients With Sepsis After Immunotherapy

May 24, 2021 updated by: Wu Jianfeng, Sun Yat-sen University

Long-term Prognosis After Thymosin Alpha 1 Treatment in Patients With Sepsis: A Multicenter Cohort Study

Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy.

Based on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sepsis patients who discharged from hospital after recovery in the TESTS study

Description

Inclusion Criteria:

  • Sepsis patients in the TESTS study Patients who discharged from hospital after recovery

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
thymosin α1 group
The patient was treated with thymosin α1 in sepsis
Drug: Thymosin Alpha1
Drug interventions have been done in previous clinical studies
placebo group
The patient was treated without thymosin α1 in sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
three years mortality
Time Frame: 3 years
Mortality rate of patients treated with thymosin α1 or placebo within 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of sepsis
Time Frame: 5 years
Percentage of recurrent sepsis within 5 years of discharge sepsis patients
5 years
one year mortality
Time Frame: 1 year
Mortality rate of patients treated with thymosin α1 or placebo within 1 year
1 year
Five years mortality
Time Frame: 5 years
Mortality rate of patients treated with thymosin α1 or placebo within 5 years
5 years
short form 36 questionnaire
Time Frame: 1 year
Quality of life of sepsis patients after 1 year of thymosin α1 or placebo treatment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

March 31, 2027

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Long-term prognosis in sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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