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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
1. Hospitalized patients aged 18 years or older with a clinical diagnosis of pneumonia.
2. 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.
3. 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.
4. 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.
Primary outcome measure(s)
Time to First Lower Respiratory Tract Infection Event — 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.
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou
Henan
More Henan University of Traditional Chinese Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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