Follow-up on patients with severe fever and thrombocytopenia syndrome

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

This study looks at the experiences and outcomes of patients with severe fever and thrombocytopenia syndrome to see how the illness affects them and what treatments work best.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 8 sites (Guangshui, Hubei and 7 other locations)
• Trial ID: NCT06011902 on ClinicalTrials.gov

What this trial studies

This observational study analyzes the clinical features, laboratory indicators, imaging changes, treatment options, and long-term prognosis of patients diagnosed with severe fever with thrombocytopenia syndrome (SFTS). It includes data from hospitalized patients diagnosed between 2016 and 2022 across eight medical centers. The study utilizes electronic medical records to collect comprehensive information on demographics, hospitalization details, clinical data, and outcomes related to SFTS.

Who should consider this trial

Good fit: Ideal candidates are hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome who meet specific laboratory criteria.

Not a fit: Patients with other tick-borne infections or those unable to participate in follow-up due to severe health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of SFTS and improve patient management and outcomes.

How similar studies have performed: While there may be limited studies on SFTS, similar observational studies have provided valuable insights into other infectious diseases, suggesting potential for meaningful findings.

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.

Where this trial is running

Guangshui, Hubei and 7 other locations

• NO.1 Peoples Hospital of Guangshui — Guangshui, Hubei, China (Recruiting)
• Huanggang Central Hospital — Huanggang, Hubei, China (Recruiting)
• People's Hospital Of Luotian County — Huanggang, Hubei, China (Recruiting)
• People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology — Macheng, Hubei, China (Recruiting)
• Suizhou Central Hospital — Suizhou, Hubei, China (Recruiting)
• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Xianning Central Hospital — Xianning, Hubei, China (Recruiting)
• Yichang Third Peoples Hospital — Yichang, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Qin Ning, Professor

Conditions Severe Fever With Thrombocytopenia Syndrome