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NCT Number: NCT07797686

TCM Cohort for Elderly CAP

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.

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Key information

Conditions

Community-Acquired Pneumonia (CAP) Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Chinese medicine (TCM)

Drug

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).

Non-traditional Chinese medicine (non-TCM)

Drug

All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.

Primary outcomes

  1. 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

  1. Length of hospital stay

    Time frame: From Day 0 of treatment to Week 2 of follow-up.

    Total number of days of hospitalization.

  2. Time to clinical stability

    Time frame: 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).

  3. modified Clinician Reported Outcome for CAP (mCAP-CRO)

    Time frame: 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.

  4. modified Patient Reported Outcome for CAP (mCAP-PRO)

    Time frame: 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.

  5. Sequential Organ Failure Assessment (SOFA)

    Time frame: 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.

  6. Confusion, Urea, Respiratory rate, Blood pressure, Age≥65 (CURB-65)

    Time frame: 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.

  7. Pneumonia Severity Index (PSI)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haifeng Wang

CONTACT

[email protected]

+86-0371-66207856

Jiansheng Li

CONTACT

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Collaborators

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Registry information

Official study title

A Prospective Traditional Chinese Medicine Cohort Study of Community-acquired Pneumonia in the Elderly

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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