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A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome

Sponsor
Tongji Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06011902
Collaborator
(none)
1,500
Enrollment
8
Locations
29.2
Anticipated Duration (Months)
187.5
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, retrospective clinical study to analyze the clinical features, laboratory indicators, imaging changes, treatment options and long-term prognosis in patients with sever fever with thrombocytopenia syndrome. All hospitalized patients with sever fever with thrombocytopenia diagnosed between 2016 and 2022 were included from the electronic medical record system of 8 centers, and demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment options, and outcomes were collected.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome
    Actual Study Start Date :
    Oct 25, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Mar 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. The presense of clinical symptoms of patients at 3 months and 6 months after discharge [3 months,6 months]

      The number and severity of clinical symptoms of patients.

    Secondary Outcome Measures

    1. Number of participants with different outcome of disease [6 months]

      Number of participants who experience these events: discharge with improvement death automatic discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age and gender are not limited;

    • Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome have at least one of the following laboratory test results: serum severe fever with thrombocytopenia syndrome bunyavirus (SFTSV)-specific IgM antibody positive or IgG antibody level increased more than 4 times; or positive for SFTSV RNA; or positive for SFTSV nucleic acid detected by real-time fluorescent quantitative RT-PCR; or SFTSV isolated from case specimens.

    Exclusion Criteria:

    • Patients who were found to be positive for other tick-borne pathogens by PCR analysis of blood samples in the acute phase;

    • It is difficult to conduct outpatient follow-up due to mental disorders, dementia, combined diseases such as osteoarthropathy, stroke, pulmonary embolism, etc. that lead to inability to move freely;

    • No outpatient follow-up visit after discharge, and repeated confirmation by phone call still unable to get in touch;

    • Due to living in other places, nursing homes, welfare homes, unable to participate in outpatient follow-up after making an appointment by phone;

    • Currently participating in clinical trials of other drugs or medical devices;

    • The researchers think it is not suitable for inclusion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NO.1 Peoples Hospital of Guangshui Guangshui Hubei China
    2 Huanggang Central Hospital Huanggang Hubei China
    3 People's Hospital Of Luotian County Huanggang Hubei China
    4 People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology Macheng Hubei China
    5 Suizhou Central Hospital Suizhou Hubei China
    6 Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China 430030
    7 Xianning Central Hospital Xianning Hubei China
    8 Yichang Third Peoples Hospital Yichang Hubei China

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qin Ning, Director and Chair of Department of Infectious Diseases, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT06011902
    Other Study ID Numbers:
    • RESORT
    First Posted:
    Aug 25, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Aug 1, 2023
    Additional relevant MeSH terms:
    Severe Fever with Thrombocytopenia Syndrome
    Thrombocytopenia
    Syndrome
    Fever

    Study Results

    No Results Posted as of Aug 25, 2023