A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome
1 other identifier
observational
1,500
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2021
CompletedFirst Submitted
Initial submission to the registry
August 8, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedAugust 25, 2023
August 1, 2023
2.2 years
August 8, 2023
August 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The presense of clinical symptoms of patients at 3 months and 6 months after discharge
The number and severity of clinical symptoms of patients.
3 months,6 months
Secondary Outcomes (1)
Number of participants with different outcome of disease
6 months
Eligibility Criteria
Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome from 8 centers in Hubei Province, China.
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (8)
NO.1 Peoples Hospital of Guangshui
Guangshui, Hubei, China
Huanggang Central Hospital
Huanggang, Hubei, China
People's Hospital Of Luotian County
Huanggang, Hubei, China
People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology
Macheng, Hubei, China
Suizhou Central Hospital
Suizhou, Hubei, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Xianning Central Hospital
Xianning, Hubei, China
Yichang Third Peoples Hospital
Yichang, Hubei, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director and Chair of Department of Infectious Diseases
Study Record Dates
First Submitted
August 8, 2023
First Posted
August 25, 2023
Study Start
October 25, 2021
Primary Completion
December 31, 2023
Study Completion
March 31, 2024
Last Updated
August 25, 2023
Record last verified: 2023-08