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TCM Cohort for Elderly CAP

ConditionCommunity-acquired Pneumonia (CAP)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorHenan University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients diagnosed with CAP;

Age ≥ 60 years old;

Voluntary participation in this study, and sign the informed consent form.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

2,234 Participants
are divided into 2 treatment groups
Group A: Traditional Chinese Medicine cohort1 intervention
Group B: Non-Traditional Chinese Medicine cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Length of hospital stay

Total number of days of hospitalization.

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

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.
3

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.
4

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.

Time frame
Baseline, weeks 1, 4 and 12.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan University of Traditional Chinese Medicine

Lead sponsor

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborator

The First Affiliated Hospital of Guangzhou Medical University

Collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: