NCT04694430Unknown不适用
A Integration of Respiratory Medicine and Prevention Multi-center Study to Determine the Prevalence and Influence of Pertussis on Chronic Obstructive Pulmonary Disease Exacerbation in Shenzhen by National Respiratory Diseases Clinical Medicine Research Center
Shenzhen People's Hospital27 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 27
- 主要终点
- Evaluation of the prevalence of pertussis among COPD
研究概览
简要总结
A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of chronic obstructive pulmonary disease (COPD) pertussis and the impact of pertussis on COPD exacerbation.
详细描述
- Investigate the incidence and epidemiological characteristics of pertussis infection in COPD population.
- To explore the relationship between pertussis infection and COPD exacerbation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute COPD
排除标准
- •Major diseases except COPD; Significant abnormality in laboratory examination; Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilation dysfunction; Patients with a history of asthma, allergic rhinitis, or a blood eosinophil count of 2600/mm3 (0.6x10^9/L) within 4 weeks; Currently suffering from active tuberculosis; Patients with life-threatening pulmonary embolism, or al-antitrypsin deficiency, or cystic fibrosis; Patients who have undergone lung resection.
结局指标
主要结局
Evaluation of the prevalence of pertussis among COPD
时间窗: Day 0 of each subject at the time of enrollment.
According to the positive rate of bordetella pertussis nucleic acid, evaluate the prevalence of pertussis in COPD.
Evaluation of the correlation between pertussis and COPD exacerbation
时间窗: Day 0 of each subject at the time of enrollment.
Evaluate the correlation between pertussis infection and COPD exacerbation by pertussis positive rate and exacerbation degree.
次要结局
- Evaluation of the cut-off value for serological diagnosis of pertussis.(Day 0 of each subject at the time of enrollment.)
- Evaluation of the seroprevalence of Bordetella pertussis in COPD(Day 0 of each subject at the time of enrollment.)
- Evaluation of the subtype of bordetella pertussis.(Day 0 of each subject at the time of enrollment.)
研究者
研究点 (27)
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