Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Microbiological profile of lower respiratory tract specimens
研究概览
简要总结
This study is aimed to understand the clinical characteristics, etiology and resistance phenotype of major pathogens of SCAP in China through multicenter and prospective investigation. Thus to provide epidemiological basis for improving the SCAP diagnosis and treatment protocol suitable for China.
详细描述
During the study period, all patients who are diagnosed with SCAP and meet the inclusion criteria in the participating unit should be enrolled in the study . At the end of the trial, each participating unit should complete at least 20 qualified cases, and all participating units should have a total of more than 300 qualified cases.
- Learn about the etiology of SCAP in China.
- Grasp the resistance phenotype and molecular epidemiology of major pathogens of SCAP in China.
- Know the important clinical characteristics of SCAP in China, including age, basic diseases, length of hospital stay, length of stay in ICU, duration of mechanical ventilation, clinical manifestations, imaging findings, complications, mortality, etc.
- Analyze and clarify the clinical risk factors of affecting SCAP mortality.
- Understand the current situation of antibiotic treatment of SCAP in China.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 yeas;
- •Diagnosis of CAP according to the diagnosis and treatment of community-acquired pneumonia in adults: 2016 clinical practice guidelines by the Chinese Thoracic Society, Chinese Medical Association.
排除标准
- •Bronchiectasis;
- •Active tuberculosis;
- •Aspiration pneumonia or obstructive pneumonia;
- •Hospitalized in 2 weeks;
- •Hospitalized or ventilated ≥5 days;
- •Severe immunosuppression patients;
- •Irregular follow-up and lost follow-up;
- •Withdraw from the study for any reason.
结局指标
主要结局
Microbiological profile of lower respiratory tract specimens
时间窗: Day 0 of the study
Record the microbiological profile of lower respiratory tract specimens, including sputum, nasopharyngeal swabs, tracheobronchial aspirates and BAL fluid.
Microbiological profile of urine specimens
时间窗: Day 0 of the study
Record the microbiological profile of urine specimens, including all the bacteria explored,especially legionella or streptoccus pneumonia.
Microbiological profile of serum specimens
时间窗: Day 0,14 days or 21 days of the study
Record the microbiological profile of serum specimens , including all the bacteria explored, especially legionella, mycoplasma, chlamydia.
次要结局
- General conditions of the participants(Day 0 of the study)
- Inflammatory Parameters(Day 0, 3 days of the study, and until the end of the study(approximately 1 year).)
- Arterial Blood Gas analysis of the participants(Day 0 of the study)
- Chest Image of the participants(Day 0 of the study)
- Pneumonia Severity Index of the participants(Day 0 of the study)
- CURB-65 Score of the participants(Day 0 of the study)
- Prognosis of the SCAP participants(up to 3 days of the study and until the end of the study(approximately 1 year).)
研究者
Jieming QU
Associate Chief Respiratory Physician
Ruijin Hospital