Traditional Chinese Medicine for Drug-Resistant Bacterial Pneumonia (DRBP-TCM)

A Multicenter Prospective Cohort Study of Traditional Chinese Medicine Treatment for Drug-Resistant Bacterial Pneumonia

This is a multicenter prospective observational cohort study of hospitalized adults with drug-resistant bacterial pneumonia. The study will compare patients who receive systemic traditional Chinese medicine treatment during routine clinical care with those who do not receive systemic traditional Chinese medicine treatment. Systemic traditional Chinese medicine treatment may include Chinese herbal decoctions, oral Chinese patent medicines, or Chinese medicine injections.

The main purpose of this study is to evaluate whether systemic traditional Chinese medicine treatment is associated with a lower risk of lower respiratory tract infection events within 180 days after hospital discharge. Other outcomes will include mortality, rehospitalization, bacterial clearance, clinical cure at discharge, antibiotic use, pneumonia-related clinical scores, quality of life, inflammatory markers, imaging changes, safety indicators, and direct medical costs.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug-Resistant Bacterial Pneumonia

Detailed Description

Drug-resistant bacterial pneumonia remains a major clinical challenge due to limited antimicrobial options, increased risk of treatment failure, recurrent infection, and prolonged antimicrobial exposure. Traditional Chinese medicine (TCM) has been widely used as an adjunctive therapy in clinical practice for patients with infectious diseases in China; however, its potential association with long-term outcomes in patients with drug-resistant bacterial pneumonia has not been sufficiently evaluated in real-world settings.

This study is designed as a multicenter prospective observational cohort study conducted in hospitalized adults with drug-resistant bacterial pneumonia. The study aims to evaluate the association between systemic TCM treatment and clinical outcomes under routine medical practice conditions. Systemic TCM treatment is defined as physician-prescribed administration of Chinese herbal decoctions, oral Chinese patent medicines, or injectable Chinese medicines during hospitalization.

This study does not assign or modify clinical treatment. Decisions regarding antimicrobial therapy, supportive care, and TCM administration are determined by treating physicians according to routine clinical practice and relevant clinical guidelines. Patients will be categorized according to whether they receive systemic TCM treatment during hospitalization, and outcomes will be compared between exposure groups.

The study will provide real-world evidence regarding the potential role of adjunctive TCM treatment in the clinical management of patients with drug-resistant bacterial pneumonia, with particular focus on subsequent infection events, clinical recovery, antimicrobial exposure, and long-term outcomes.

• Study Type: Observational
• Enrollment (Estimated): 528

Contacts and Locations

• Study Contact: Name: Zhenzhen Feng, Doctor; Phone Number: +86 15890658268; Email: huxifzz@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • First Affiliated Hospital of Henan University of Traditional Chinese Medicine
      • Contact: Zhenzhen Feng, Doctor; Phone Number: +86 15890658268; Email: huxifzz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adults with clinically diagnosed pneumonia and microbiologically confirmed drug-resistant bacterial pathogens will be enrolled from participating centers. Eligible participants may include patients with community-acquired pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia. Drug-resistant bacterial pneumonia will be defined as pneumonia with an isolated bacterial strain resistant to at least one commonly used antimicrobial agent, with the isolate judged to represent a causative pathogen rather than colonization or contamination.

Description

Inclusion Criteria:

1. Hospitalized patients diagnosed with pneumonia.
2. Microbiological testing indicates that the isolated bacterial strain is resistant to at least one commonly used antimicrobial agent based on standard antimicrobial susceptibility testing.
3. The isolated bacterial strain is judged to be a causative pathogen rather than colonization or contamination based on clinical manifestations, imaging findings, microbiological results, and treatment response.
4. Age 18 years or older.
5. Willing to participate in the study and able to provide written informed consent.

Exclusion Criteria:

1. Patients who are unable to complete data collection due to unconsciousness, dementia, impaired consciousness, psychiatric illness, or other conditions, and for whom relevant information cannot be obtained through a legally authorized representative or family member.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Traditional Chinese Medicine Cohort; Participants who receive systemic traditional Chinese medicine treatment after enrollment during routine clinical care. Systemic traditional Chinese medicine treatment includes Chinese herbal decoctions, oral Chinese patent medicines, and Chinese medicine injections. External traditional Chinese medicine therapies will be recorded separately. The study does not assign treatment.
Non-Systemic Traditional Chinese Medicine Cohort; Participants who do not receive systemic traditional Chinese medicine treatment after enrollment during routine clinical care. Conventional diagnosis, antimicrobial therapy, supportive care, and other clinical management will be determined by treating physicians according to routine clinical practice and relevant guidelines. The study does not assign treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Lower Respiratory Tract Infection Event	Time from hospital discharge to the first lower respiratory tract infection event. Lower respiratory tract infection events include relapse of drug-resistant bacterial pneumonia, new pneumonia, acute lower respiratory tract infection, or acute exacerbation of chronic airway disease complicated by lower respiratory tract infection. Events will be assessed based on symptoms, signs, inflammatory biomarkers, chest imaging, microbiological findings, and response to antimicrobial treatment.	From hospital discharge to 180 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number and proportion of participants who die during hospitalization or follow-up.	At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.
Rehospitalization	Number and proportion of participants who are rehospitalized after discharge.	At 30, 90, and 180 days after discharge
Upper Respiratory Tract Infection Events	Number and proportion of participants with upper respiratory tract infection events, including common cold, acute viral pharyngitis, or laryngitis.	From discharge to 180 days after discharge
Bacterial Clearance	Number and proportion of participants with confirmed or presumed clearance of the target causative pathogen. Confirmed clearance is defined as no detection of the target pathogen on follow-up microbiological testing. Presumed clearance is defined as clinical improvement without evidence of infection progression or relapse when follow-up microbiological testing is unavailable.	At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).
Clinical Cure	Number and proportion of participants with clinical cure at discharge. Clinical cure is defined as resolution or return to pre-infection status of pneumonia-related symptoms and signs, improvement or normalization of non-microbiological laboratory indicators, radiographic absorption or partial absorption, and no further need for antibacterial therapy for the index pneumonia.	At discharge from the initial hospitalization (up to 90 days after enrollment)
Antibiotic Treatment Days	Total number of days of antibacterial therapy from enrollment to discharge or end of treatment, including broad-spectrum or special-grade antibiotic use and combination therapy.	From enrollment through discontinuation of antibacterial therapy or hospital discharge, whichever occurs first (up to 90 days after enrollment).
Modified Community-Acquired Pneumonia Clinician-Reported Outcome Score	Pneumonia-related clinical status will be assessed using the Modified Community-Acquired Pneumonia Clinician-Reported Outcome Scale. 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 0 to 4, and the item scores are summed to produce a total score ranging from 0 to 44. Higher scores indicate more severe pneumonia-related symptoms and signs and less clinical improvement.	At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge
Modified Community-Acquired Pneumonia Patient-Reported Outcome Score	Pneumonia-related symptoms and patient-perceived health status will be assessed using the Modified Community-Acquired Pneumonia Patient-Reported Outcome Scale. 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, and the item scores are summed to produce a total score ranging from 0 to 68. Higher scores indicate more severe pneumonia-related symptoms, greater impairment in daily functioning, and lower satisfaction with health status and treatment effectiveness.	At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge
36-Item Short Form Health Survey Score	Health-related quality of life will be assessed using the 36-Item Short Form Health Survey. The instrument evaluates eight health domains. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life.	At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Investigators: Study Chair: Jiansheng Li, Doctor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hospital-acquired pneumonia; Traditional Chinese medicine; Ventilator-associated pneumonia; Antimicrobial resistance; Prospective cohort; Community-acquired pneumonia; Rehospitalization; Lower respiratory tract infection; Drug-resistant bacteria
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Community-Acquired Pneumonia
• Other Study ID Numbers: TCM for DRBP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No