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

August 21, 2023 updated by: Qin Ning, Tongji Hospital
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1500

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 Locations

  • China
    • Hubei
      • Guangshui, Hubei, China
      • Huanggang, Hubei, China
      • Huanggang, Hubei, China
        • Recruiting
        • People's Hospital of Luotian County
        • Contact:
      • Macheng, Hubei, China
        • Recruiting
        • People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology
        • Contact:
      • Suizhou, Hubei, China
        • Recruiting
        • Suizhou Central Hospital
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
      • Xianning, Hubei, China
      • Yichang, Hubei, China
        • Recruiting
        • Yichang Third Peoples Hospital
        • Contact:

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

Sampling Method

Probability Sample

Study Population

Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome from 8 centers in Hubei Province, China.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presense of clinical symptoms of patients at 3 months and 6 months after discharge
Time Frame: 3 months,6 months
The number and severity of clinical symptoms of patients.
3 months,6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with different outcome of disease
Time Frame: 6 months

Number of participants who experience these events:

  1. discharge with improvement
  2. death
  3. automatic discharge
6 months

Collaborators and Investigators

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

Sponsor

Tongji Hospital

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 (Actual)

October 25, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESORT

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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