Clinical trial NCT06011902: A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome
Official title: A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Fever With Thrombocytopenia Syndrome
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome from 8 centers in Hubei Province, China.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The presense of clinical symptoms of patients at 3 months and 6 months after discharge
timeFrame: 3 months,6 months
Secondary outcomes:
measure: Number of participants with different outcome of disease
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangshui
country: China
facility: NO.1 Peoples Hospital of Guangshui
state: Hubei
city: Huanggang
country: China
facility: Huanggang Central Hospital
state: Hubei
city: Huanggang
country: China
facility: People's Hospital Of Luotian County
state: Hubei
city: Macheng
country: China
facility: People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology
state: Hubei
city: Suizhou
country: China
facility: Suizhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Xianning
country: China
facility: Xianning Central Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Third Peoples Hospital
state: Hubei
Study officials:
References: