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NCT Number: NCT07726095

Systemic Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia

This is a multicenter prospective observational cohort study of hospitalized patients with multidrug-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 primary objective 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. Secondary outcomes include mortality, rehospitalization, bacterial clearance, clinical cure at hospital discharge, duration of antibacterial therapy, pneumonia-related clinician-reported and patient-reported outcome scores, health-related quality of life, inflammatory markers, imaging changes, safety outcomes, and direct medical costs.

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Key information

Conditions

Multi Drug Resistant Infections Community-Acquired Infections Community-Acquired Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumnia Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location contact

Zhenzhen Feng, Doctor

CONTACT

[email protected]

+86 15890658268

About this study

Multidrug-resistant bacterial pneumonia remains a major clinical challenge because of limited effective antimicrobial options, an increased risk of treatment failure and recurrent infection, and prolonged antimicrobial exposure. Traditional Chinese medicine (TCM) is commonly used as an adjunctive treatment in clinical practice in China; however, the association between systemic TCM treatment and the prognosis of patients with multidrug-resistant bacterial pneumonia has not been adequately evaluated in real-world settings.

This multicenter prospective observational cohort study will enroll hospitalized patients with multidrug-resistant bacterial pneumonia. The study is designed to evaluate the association between systemic TCM treatment received during routine clinical care and subsequent patient outcomes. Systemic TCM treatment is defined as physician-prescribed treatment with Chinese herbal decoctions, oral Chinese patent medicines, or Chinese medicine injections during hospitalization.

The study will not assign, mandate, or modify any clinical treatment. Decisions regarding antimicrobial therapy, supportive care, and TCM treatment will be made independently by the treating physicians according to the patient's clinical condition, routine clinical practice, and relevant clinical guidelines. Participants will be categorized according to whether they receive systemic TCM treatment during hospitalization, and outcomes will be compared between the exposed and unexposed groups.

This study is intended to generate real-world evidence regarding the potential role of systemic TCM treatment as an adjunct to routine clinical management in patients with multidrug-resistant bacterial pneumonia, particularly in relation to subsequent respiratory infection events, clinical recovery, antimicrobial exposure, and longer-term prognosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized patients aged 18 years or older with a clinical diagnosis of pneumonia.
  • Microbiological testing identifies at least one bacterial isolate that meets the definition of multidrug resistance, defined as acquired non-susceptibility to at least one antimicrobial agent in each of three or more antimicrobial categories, based on standard antimicrobial susceptibility testing.
  • The multidrug-resistant bacterial isolate is judged to be a causative pathogen of the current pneumonia episode rather than colonization or contamination, based on clinical manifestations, imaging findings, microbiological results, and the clinical course.
  • Willing to participate in the study and able to provide written informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Time to First Lower Respiratory Tract Infection Event

    Time frame: From hospital discharge to 180 days after discharge

    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.

Secondary outcomes

  1. Mortality

    Time frame: At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.

    Number and proportion of participants who die during hospitalization or follow-up.

  2. Rehospitalization

    Time frame: At 30, 90, and 180 days after discharge

    Number and proportion of participants who are rehospitalized after discharge.

  3. Upper Respiratory Tract Infection Events

    Time frame: From discharge to 180 days after discharge

    Number and proportion of participants with upper respiratory tract infection events, including common cold, acute viral pharyngitis, or laryngitis.

  4. Bacterial Clearance

    Time frame: At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).

    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.

  5. Clinical Cure

    Time frame: At discharge from the initial hospitalization (up to 90 days after enrollment)

    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.

  6. Antibiotic Treatment Days

    Time frame: From enrollment through discontinuation of antibacterial therapy or hospital discharge, whichever occurs first (up to 90 days after enrollment).

    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.

  7. Modified Community-Acquired Pneumonia Clinician-Reported Outcome Score

    Time frame: At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge

    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.

  8. Modified Community-Acquired Pneumonia Patient-Reported Outcome Score

    Time frame: At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge

    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.

  9. 36-Item Short Form Health Survey Score

    Time frame: At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenzhen Feng, Doctor

CONTACT

[email protected]

+86 15890658268

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Registry information

Official study title

A Multicenter Prospective Observational Cohort Study of Systemic Traditional Chinese Medicine Treatment in Multidrug-Resistant Bacterial Pneumonia

Acronym: MDRBP-TCM

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 24, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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