A Prospective Traditional Chinese Medicine Cohort Study of Community-acquired Pneumonia in the Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 2,234
- Locations
- 1
- Primary Endpoint
- 90-day all-cause readmission rate
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients diagnosed with CAP;
- •Age ≥ 60 years old;
- •Voluntary participation in this study, and sign the informed consent form.
Exclusion Criteria
- •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.
Arms & Interventions
Traditional Chinese Medicine cohort
Regulated use of Chinese medicine treatment protocols is included as an exposure factor.
Intervention: 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.
Intervention: Non-traditional Chinese medicine (non-TCM) (Drug)
Outcomes
Primary Outcomes
90-day all-cause readmission rate
Time Frame: Up to week 12.
The 90-day all-cause readmission rate will be calculated in each group at the end of the trial.
Secondary Outcomes
- 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.)