TCM Cohort for Elderly CAP
28 augusti 2026 uppdaterad av: Henan University of Traditional Chinese Medicine
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
2234
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Haifeng Wang
- Telefonnummer: +86-0371-66207856
- E-post: wangh_f@126.com
Studera Kontakt Backup
- Namn: Jiansheng Li
Studieorter
-
-
Henan
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Zhengzhou, Henan, Kina, 450000
- The First Affiliated Hospital of Henan University of Chinese Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Traditional Chinese Medicine cohort
Regulated use of Chinese medicine treatment protocols is included as an exposure factor.
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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).
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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.
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Alla interventionsåtgärder som inte uppfyller kriterierna för TCM-exponering betraktas som exponering för icke-TCM.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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90-day all-cause readmission rate
Tidsram: Up to week 12.
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The 90-day all-cause readmission rate will be calculated in each group at the end of the trial.
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Up to week 12.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Length of hospital stay
Tidsram: From Day 0 of treatment to Week 2 of follow-up.
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Total number of days of hospitalization.
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From Day 0 of treatment to Week 2 of follow-up.
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Time to clinical stability
Tidsram: From enrollment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to Week 2.
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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).
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From enrollment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to Week 2.
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modified Clinician Reported Outcome for CAP (mCAP-CRO)
Tidsram: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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modified Patient Reported Outcome for CAP (mCAP-PRO)
Tidsram: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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Sequential Organ Failure Assessment (SOFA)
Tidsram: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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Confusion, Urea, Respiratory rate, Blood pressure, Age≥65 (CURB-65)
Tidsram: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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Pneumonia Severity Index (PSI)
Tidsram: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Haifeng Wang, The First Affiliated Hospital of Henan University of Chinese Medicine
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
20 augusti 2026
Primärt slutförande (Beräknad)
31 december 2029
Avslutad studie (Beräknad)
28 februari 2030
Studieregistreringsdatum
Först inskickad
19 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
28 augusti 2026
Första postat (Faktisk)
1 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Cohort for Elderly CAP
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