Community-acquired Pneumonia (CAP)NCT07797686
TCM Cohort for Elderly CAP
An observational study of Community-acquired Pneumonia (CAP), run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-acquired Pneumonia (CAP)
- What is being tested?
- Traditional Chinese medicine (TCM) and Non-traditional Chinese medicine (non-TCM)
- How many people
- 2,234 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 28 Feb 2030
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CAP refers to infectious inflammation of the lung parenchyma that is acquired outside the hospital, and includes pneumonia that develops during the incubation period after hospitalization when the infection is caused by a pathogen with a known incubation period.
Who may be able to join
- Patients diagnosed with CAP;
- Age ≥ 60 years old;
- Voluntary participation in this study, and sign the informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jiansheng Li contact
China1 site
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000
About this study
Official title: A Prospective Traditional Chinese Medicine Cohort Study of Community-acquired Pneumonia in the Elderly
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.
Read the 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.
- Conditions
- Community-acquired Pneumonia (CAP)
- Being tested
- Traditional Chinese medicine (TCM), Non-traditional Chinese medicine (non-TCM)
- Keywords
- Community-acquired Pneumonia in the Elderly, Cohort Study, Traditional Chinese Medicine Syndromes, Biomarkers
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine cohort | Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Receives: Drug: Traditional Chinese medicine (TCM) | |
| 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. Receives: Drug: Non-traditional Chinese medicine (non-TCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to week 12.
Secondary outcomes (7)
Length of hospital stay
Total number of days of hospitalization.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, weeks 1, 4 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start20 Aug 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,234 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Haifeng Wang, Principal investigator, The First Affiliated Hospital of Henan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797686
- Sponsor's protocol ID
- Cohort for Elderly CAP
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Traditional Chinese Medicine Cohort Study of Community-acquired Pneumonia in the Elderly
- ClinicalTrials.gov ID
- NCT07797686
- Acronym / sponsor ID
- Cohort for Elderly CAP
- Conditions
- Community-acquired Pneumonia (CAP)
- Keywords
- Community-acquired Pneumonia in the Elderly, Cohort Study, Traditional Chinese Medicine Syndromes, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,234 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- 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 start
- 20 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine cohort | – | Drug: Traditional Chinese medicine (TCM)Regulated use of Chinese medicine treatment protocols is included as an exposure factor. |
| Non-Traditional Chinese Medicine cohort | – | Drug: Non-traditional Chinese medicine (non-TCM)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CAP refers to infectious inflammation of the lung parenchyma that is acquired outside the hospital, and includes pneumonia that develops during the incubation period after hospitalization when the infection is caused by a pathogen with a known incubation period.
Key inclusion criteria (3 listed)
- Patients diagnosed with CAP;
- Age ≥ 60 years old;
- Voluntary participation in this study, and sign the informed consent form.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese medicine (TCM)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). | Drug | Traditional Chinese Medicine cohort |
| Non-traditional Chinese medicine (non-TCM)All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure. | Drug | Non-Traditional Chinese Medicine cohort |
Primary outcome
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.
7 secondary outcomes
Length of hospital stay
Time frame: From Day 0 of treatment to Week 2 of follow-up.
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.
modified Clinician Reported Outcome for CAP (mCAP-CRO)
Time frame: Baseline, weeks 1, 4 and 12.
modified Patient Reported Outcome for CAP (mCAP-PRO)
Time frame: Baseline, weeks 1, 4 and 12.
Sequential Organ Failure Assessment (SOFA)
Time frame: Baseline, weeks 1, 4 and 12.
Confusion, Urea, Respiratory rate, Blood pressure, Age≥65 (CURB-65)
Time frame: Baseline, weeks 1, 4 and 12.
Pneumonia Severity Index (PSI)
Time frame: Baseline, weeks 1, 4 and 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiansheng Li contact
Haifeng Wang principal investigator
The First Affiliated Hospital of Henan University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia (CAP), run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haifeng Wang (+86-0371-66207856, wangh_f@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day all-cause readmission rate (time frame: Up to week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.