A Prospective Traditional Chinese Medicine Cohort Study of Community-acquired Pneumonia in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,234
- 试验地点
- 1
- 主要终点
- 90-day all-cause readmission rate
研究概览
简要总结
This study evaluates the real-world clinical efficacy of traditional Chinese medicine (TCM) in elderly Community-acquired pneumonia (CAP) patients and explores syndrome characteristics and their associations with biomarkers.
详细描述
This prospective cohort study, with TCM as the exposure, will enroll 2,234 elderly CAP patients for a 12-week follow-up. The primary evaluation uses the 90-day all-cause readmission rate as the outcome to evaluate the clinical efficacy of TCM. In addition, the study will investigate the characteristics of TCM syndromes.
Based on the cohort, we will collect peripheral blood, exhaled breath condensate, sputum, and tongue coating samples from 200 elderly CAP patients with four typical TCM syndromes, 200 non-elderly CAP patients with corresponding syndromes, and 50 healthy volunteers. Multi-omics approaches will be used to identify TCM syndrome-related biomarkers.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with CAP;
- •Age ≥ 60 years old;
- •Voluntary participation in this study, and sign the informed consent form.
排除标准
- •Patients with various mental illnesses or other conditions that prevent normal communication;
- •Patients with a history of pulmonary surgery, such as lung volume reduction surgery or lung transplantation;
- •Patients with confirmed human immunodeficiency virus infection or acquired immunodeficiency syndrome.
研究组 & 干预措施
Traditional Chinese Medicine cohort
Regulated use of Chinese medicine treatment protocols is included as an exposure factor.
干预措施: Traditional Chinese medicine (TCM) (Drug)
Non-Traditional Chinese Medicine cohort
Other elderly CAP patients who do not meet the inclusion criteria for traditional Chinese medicine cohort, are classified into the non-traditional Chinese medicine cohort.
干预措施: Non-traditional Chinese medicine (non-TCM) (Drug)
结局指标
主要结局
90-day all-cause readmission rate
时间窗: Up to week 12.
The 90-day all-cause readmission rate will be calculated in each group at the end of the trial.
次要结局
- Length of hospital stay(From Day 0 of treatment to Week 2 of follow-up.)
- Time to clinical stability(From enrollment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to Week 2.)
- modified Clinician Reported Outcome for CAP (mCAP-CRO)(Baseline, weeks 1, 4 and 12.)
- modified Patient Reported Outcome for CAP (mCAP-PRO)(Baseline, weeks 1, 4 and 12.)
- Sequential Organ Failure Assessment (SOFA)(Baseline, weeks 1, 4 and 12.)
- Confusion, Urea, Respiratory rate, Blood pressure, Age≥65 (CURB-65)(Baseline, weeks 1, 4 and 12.)
- Pneumonia Severity Index (PSI)(Baseline, weeks 1, 4 and 12.)