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NCT Number: NCT04901104

Long-term Prognosis of Patients With Sepsis After Immunotherapy

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.

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Key information

Conditions

Long-term Effects of Thymosin Alpha 1 Treatment Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Thymosin Alpha1

Drug

Drug interventions have been done in previous clinical studies

Primary outcomes

  1. three years mortality

    Time frame: 3 years

    Mortality rate of patients treated with thymosin α1 or placebo within 3 years

Secondary outcomes

  1. Recurrence rate of sepsis

    Time frame: 5 years

    Percentage of recurrent sepsis within 5 years of discharge sepsis patients

  2. one year mortality

    Time frame: 1 year

    Mortality rate of patients treated with thymosin α1 or placebo within 1 year

  3. Five years mortality

    Time frame: 5 years

    Mortality rate of patients treated with thymosin α1 or placebo within 5 years

  4. short form 36 questionnaire

    Time frame: 1 year

    Quality of life of sepsis patients after 1 year of thymosin α1 or placebo treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Pei

CONTACT

[email protected]

020-87755766-8453

Jianfeng Wu

CONTACT

[email protected]

020-87755766-8453

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
May 25, 2021
Registry last updated
May 25, 2021

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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