The Fever Clinic Acute Respiratory Cohort (FACTS): A Prospective Real-World Cohort Study of Patients Presenting to Fever Clinics: Clinical Features, Laboratory and Radiographic Findings, and Long-Term Outcomes of Acute Respiratory Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proportion of Participants Hospitalized for Pneumonia
研究概览
简要总结
This prospective cohort study aims to characterize the natural progression and outcomes of acute respiratory infections among patients presenting to fever clinics. At enrollment, patients' clinical symptoms, laboratory findings, and chest imaging data will be collected. Longitudinal follow-up will be conducted to evaluate disease progression, complications, and long-term outcomes.
As an observational study, no interventions are involved; all patients receive routine clinical management as directed by their attending physicians. This real-world study design enables the assessment of the natural course of acute respiratory infections and the identification of factors associated with clinical outcomes.
详细描述
This prospective cohort study aims to characterize the natural history and outcomes of acute respiratory infection in patients presenting to fever clinics. Upon enrollment, patients' clinical symptoms, laboratory parameters, and chest imaging data will be collected. Subsequent longitudinal follow-up will be performed to assess disease progression, complications, and long-term outcomes.
As an observational study, no interventions are implemented; all patients receive standard-of-care management as determined by their attending physicians. This real-world study design allows for the evaluation of the natural progression of acute respiratory infections and the identification of factors associated with clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years (based on official identification document).
- •Presence of fever at the time of visit or within 24 hours prior to the visit, defined as a documented temperature of ≥37.3°C axillary/tympanic, ≥37.8°C orally, or ≥38.0°C rectally.
- •The primary cause of fever, as determined by the attending physician, is a respiratory tract infection.
- •Blood draw is required as part of standard clinical care.
- •Ability to comprehend the study's purpose, procedures, and potential risks, and willingness to provide written informed consent.
排除标准
- •Inability to provide independent informed consent due to impaired consciousness or other reasons.
- •Inability to comply with the study procedures.
- •Medical contraindications to blood sampling, such as severe coagulopathy (e.g., INR > 3.0, platelet count < 50 × 10⁹/L).
- •Diagnosed with a terminal illness (e.g., advanced malignancy, severe multiple organ failure) and a life expectancy of less than 3 months.
结局指标
主要结局
Proportion of Participants Hospitalized for Pneumonia
时间窗: 30 days
The percentage of patients who require hospitalization due to radiologically confirmed pneumonia within the 30-day follow-up period.
次要结局
- Rate of Symptom Resolution at 24 Hours(24 hours)
- Rate of Symptom Resolution at 7 Days(7 days)
- Time to Sustained Symptom Resolution(30 days)
- All-cause Mortality Rate at 30 Days(30 days)
- Intensive Care Unit (ICU) Admission Rate at 30 Days(30 days)
- Change in White Blood Cell (WBC) Count(Baseline, Day 3)
- Normalization Rate of C-reactive Protein (CRP)(Baseline, Day 7)
- Change in Procalcitonin (PCT) Level(Baseline, Day 3)
- Incidence of Acute Exacerbation of Underlying Chronic Diseases(30 days)
- Rate of Unplanned Medical Visits(30 days)