Systemic Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multi Drug Resistant Infections, Pneumnia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Prospective Observational Cohort Study of Systemic Traditional Chinese Medicine Treatment in Multidrug-Resistant Bacterial Pneumonia
Overview
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.
Detailed description
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.
Primary outcome measures
- Time to First Lower Respiratory Tract Infection Event [Time frame: From hospital discharge to 180 days after discharge]
Secondary outcome measures (9)
- Mortality [Time frame: At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.]
- Rehospitalization [Time frame: At 30, 90, and 180 days after discharge]
- Upper Respiratory Tract Infection Events [Time frame: From discharge to 180 days after discharge]
- Bacterial Clearance [Time frame: At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).]
- Clinical Cure [Time frame: At discharge from the initial hospitalization (up to 90 days after enrollment)]
- Antibiotic Treatment Days [Time frame: 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 [Time frame: 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 [Time frame: At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge]
- 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]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Zhengzhou
Identifiers
NCT: NCT07726095 · TCM for MDRBP