NCT04955756招募中不适用
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 3
- 主要终点
- time for targetted antibiotic treatment
研究概览
简要总结
Early identification and Severity prediction of Acute Respiratory infectious disease has become a top priority for clinicians at department of infectious and respiratory diseases after COVID-19 broke out. This is a multicenter, prospective, and randomized study, which aims to figure out the best way of early identification and severity prediction of acute respiratory infectious diseases. Patients with suspected acute respiratory infectious diseases will be enrolled into this study and received two different diagnostic pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years old
- •No limits in gender
- •Patients who are newly present with cough, sputum, or exacerbated with pyogenic sputum, with or without chest pain within 2 weeks;
- •Patients who meet at least one of the following 4 requirements:
- •Sign of pulmonary consolidation or wet wales
- •WBC>10×10^9/L or <4×10^9/L;
- •patchy, infiltrating shadows or interstitial changes, with or without pleural effusion on chest radiological examination.
排除标准
- •Highly suspected or diagnosed pulmonary non-infectious disease (Tumor, Immune disease, etc.) without evidence for infection;
- •Pathogen has been identified without evidence for co-infection;
- •Insufficiency of respiratory and blood samples;
- •Patients who are unable to collaborate due to physical or mental disorders;
- •Patients who have been engaged to other clinical trials;
- •Any conditions make it unsafe for the subject to participate;
结局指标
主要结局
time for targetted antibiotic treatment
时间窗: 28 days
time interval from enrollment to targetted antibiotic treatment initiation
次要结局
- Incidence for clinical key events(28 days)
- Incidence for clinical remission(28 days)
- Length of hospitalization;(28 days)
- Length of ICU admission(28 days)
- Length from admission to clinical events(28 days)
- Sampling to Diagnosis Interval(28 days)
研究者
Wen-hong Zhang
chairman of the infectious disease department
Huashan Hospital
研究点 (3)
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