Community-acquired Pneumonia (CAP)
Conditions
Keywords
Community-acquired Pneumonia in the Elderly, Cohort Study, Traditional Chinese Medicine Syndromes, Biomarkers
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.
Interventions
According to the standardised use of TCM protocols, the group is divided into an exposed group (TCM cohort) and an unexposed group (non-TCM cohort).
All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.
Sponsors
Henan University of Traditional Chinese Medicine
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
The First Affiliated Hospital of Guangzhou Medical University
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day all-cause readmission rate | Up to week 12. | The 90-day all-cause readmission rate will be calculated in each group at the end of the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From Day 0 of treatment to Week 2 of follow-up. | Total number of days of hospitalization. |
| Time to clinical stability | From enrollment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to Week 2. | Clinical stability is defined as meeting all of the following criteria simultaneously: body temperature \< 37.8℃, heart rate ≤ 100 beats/min, respiratory rate ≤ 24 breaths/min, systolic pressure ≥ 90mmHg, and oxygen saturation ≥ 90% (or PaO2 \< 60mmHg without oxygen inhale). |
| modified Clinician Reported Outcome for CAP (mCAP-CRO) | Baseline, weeks 1, 4 and 12. | Pneumonia-related clinical status will be assessed using the mCAP-CRO. The scale contains 11 clinician-reported items evaluating pneumonia-related symptoms and signs during the previous 24 hours and the clinician's overall assessment of disease improvement. Each item is scored from 1 to 5. Higher scores indicate more severe pneumonia-related symptoms and signs and less clinical improvement. |
| modified Patient Reported Outcome for CAP (mCAP-PRO) | Baseline, weeks 1, 4 and 12. | Pneumonia-related symptoms and patient-perceived health status will be assessed using the mCAP-PRO. The scale contains 17 patient-reported items evaluating pneumonia-related symptoms during the previous 24 hours, the effects of the illness on daily activities and work or study, and satisfaction with health status and treatment effectiveness. Each item is scored from 0 to 4. Higher scores indicate more severe pneumonia-related symptoms, greater impairment in daily functioning, and lower satisfaction with health status and treatment effectiveness. |
| Sequential Organ Failure Assessment (SOFA) | Baseline, weeks 1, 4 and 12. | The SOFA score will be used to assess the degree of organ dysfunction in elderly patients with severe CAP. The total SOFA score ranges from 0 to 24 points. The higher scores will indicate the worse outcomes. |
| Confusion, Urea, Respiratory rate, Blood pressure, Age≥65 (CURB-65) | Baseline, weeks 1, 4 and 12. | The CURB-65 score will be used to assess the severity of elderly patients with CAP. The total score ranges from 0 to 5 points. The higher scores will indicate the worse outcomes. |
| Pneumonia Severity Index (PSI) | Baseline, weeks 1, 4 and 12. | The PSI will be used to assess the disease severity in elderly CAP patients. It stratifies patients into five risk classes (I-V) according to a point-scoring system, with higher scores consistently correlating with worse outcomes. |
Countries
China
Contacts
CONTACTHaifeng Wang
CONTACTJiansheng Li
PRINCIPAL_INVESTIGATORHaifeng Wang
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed