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.
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 Type
OBSERVATIONAL
Enrollment
2,234
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.
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
90-day all-cause readmission rate
The 90-day all-cause readmission rate will be calculated in each group at the end of the trial.
Time frame: Up to week 12.
Length of hospital stay
Total number of days of hospitalization.
Time frame: From Day 0 of treatment to Week 2 of follow-up.
Time to clinical stability
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).
Time frame: 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)
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.
Time frame: Baseline, weeks 1, 4 and 12.
modified Patient Reported Outcome for CAP (mCAP-PRO)
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.
Jiansheng Li
CONTACT
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Time frame: Baseline, weeks 1, 4 and 12.
Sequential Organ Failure Assessment (SOFA)
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.
Time frame: Baseline, weeks 1, 4 and 12.
Confusion, Urea, Respiratory rate, Blood pressure, Age≥65 (CURB-65)
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.
Time frame: Baseline, weeks 1, 4 and 12.
Pneumonia Severity Index (PSI)
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.
Time frame: Baseline, weeks 1, 4 and 12.