REspiratory diSEAse cohoRt Studies of CHinese Medicine for CAP (RESEARCH- CAP)

Community Acquired Pneumonia Clinical Trial

Official title:

REspiratory diSEAse cohoRt Studies of CHinese Medicine for CAP (RESEARCH- CAP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06220019
• Other study ID #: TCM for CAP Cohort
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: Henan University of Traditional Chinese Medicine
• Contact: Minghang Wang, Doctor
• Phone: +86 371 66248624
• Email: wmh107hn[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with CAP after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.

Description:

Community acquired pneumonia (CAP) has a high incidence rate, hospitalization rate, case fatality rate and heavy disease burden. The follow-up and post discharge intervention for CAP patients are weak, and they face the risk of re hospitalization or even death due to recurrent pneumonia or other reasons. In clinical practice, more attention has been paid to the improvement of clinical symptoms during hospitalization for patients with CAP, and there is a lack of reports on continued intervention outside the hospital to reduce readmission rates. Therefore, it is necessary to conduct cohort studies on CAP.

This is a multicenter, prospective cohort study aimed at evaluating the clinical efficacy and safety of dialectical treatment for CAP patients. This cohort study will recruit approximately 1078 patients, divided into two cohorts: one is a traditional Chinese medicine cohort, and these patients have been evaluated and have shown certain effectiveness; Another non traditional Chinese medicine cohort, where participants from both cohorts will receive a one-year follow-up period. The main outcome measure is readmission rate. Secondary efficacy indicators include efficacy satisfaction, physician reported outcomes, patient reported outcomes, quality of life ，nutritional status, Acute upper respiratory tract infection (URTI) event, and Survival situation. Follow up every 3 months for 1 year.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1078
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Selection Criteria:

• CAP patients who meet the diagnostic criteria are discharged within 7 days;

• Willing to receive treatment and able to take medication orally;

• Sign an informed consent form.

Exclusion Criteria:

• Patients with confusion, consciousness disorders, dementia, and various mental illnesses;

• Patients with neuromuscular diseases and long-term bed rest who are at risk of aspiration;

• Patients infected with HIV infection or other immunodeficiency diseases;

• Participants in clinical trials of other drugs;

• Known to be allergic to treatment drugs.

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Drug:
• TCM
CAP patients diagnosed with Qi Deficiency Phlegm Dampness Syndrome or Qi Yin Deficiency Phlegm Heat Syndrome after discharge, with traditional Chinese medicine treatment as the exposure factor, will be included in the Traditional Chinese Medicine cohort. Patients who continuously take traditional Chinese medicine (modified by Bu Fei Jian Pi Hua Tan Fang or modified by Yi Qi Yang Yin Qing Fei Fang) for more than 2 months per year, or those who intermittently take medicine for more than 3 months of the total time of the year will be classified.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine	Hebei Provincial Hospital of Traditional Chinese Medicine, Qingdao Haici Hospital, Shanghai University of Traditional Chinese Medicine, Shanxi Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Wuhan No.1 Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehospitalization rate	Including all-cause readmission rate and pulmonary infection readmission rate	The Rehospitalization rate within a one-year follow-up period
Secondary	Patient satisfaction with efficacy	The Effectiveness Satisfaction Questionnaire of CAP (ESQ-CAP) was used to evaluate the efficacy of pneumonia patients.	Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Secondary	Health survey summary table(SF-36)	Using SF-36 to evaluate the impact of CAP on a person's life over time	Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Secondary	Clinical outcomes reported by patients	The Patient Reported Outcome for CAP (CAP-PRO) was used to assess the quality of life and health status of patients with pneumonia.	Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Secondary	Clinical outcomes reported by doctors	The Clinical Reported Outcome for CAP (CAP CRO) was used to assess the patient's condition.	Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Secondary	nutritional status	Nutritional status related indicators.	Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage
Secondary	Acute upper respiratory tract infection (URTI) event	It is a general term for acute inflammation of the nose, pharynx, or throat caused by various viruses and/or bacteria, including common cold, acute viral pharyngitis or laryngitis, acute herpetic pharyngitis, pharyngoconjunctival fever, bacterial pharyngitis, and tonsillitis.	Acute upper respiratory tract infection events that occurred during the one-year follow-up period
Secondary	Survival situation	Record the number of deaths. Record the follow-up period every 3 months.	Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase