A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 8
- 主要终点
- The presense of clinical symptoms of patients at 3 months and 6 months after discharge
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The presense of clinical symptoms of patients at 3 months and 6 months after discharge
时间窗: 3 months,6 months
The number and severity of clinical symptoms of patients.
次要结局
- Number of participants with different outcome of disease(6 months)
研究者
Qin Ning
Director and Chair of Department of Infectious Diseases
Tongji Hospital