MDRBP-TCM
A Multicenter Prospective Observational Cohort Study of Traditional Chinese Medicine Treatment in Multidrug-Resistant Bacterial Pneumonia
Sponsor study identifier
observational
652
1 country
1
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a multicenter prospective observational cohort study involving hospitalized adult patients with multidrug-resistant bacterial pneumonia. Patients will be categorized into two cohorts according to whether they receive systemic traditional Chinese medicine (TCM) treatment as part of routine clinical care. Systemic TCM treatment includes Chinese herbal decoctions, oral Chinese patent medicines, and Chinese medicine injections. Treatment decisions will be made by the attending physicians according to routine clinical practice, without intervention by the researchers. The primary objective is to evaluate the association between systemic TCM treatment and the occurrence of lower respiratory tract infection events within 90 days after hospital discharge. Secondary outcomes include all-cause and pneumonia-related mortality, rehospitalization, upper respiratory tract infection events, bacterial clearance, clinical cure at hospital discharge, antibacterial drug use, pneumonia-related clinician-reported and patient-reported outcomes, health-related quality of life, inflammatory markers, imaging changes, safety outcomes, and direct medical costs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2026
Actual (reported)July 24, 2026
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of Lower Respiratory Tract Infection Events Within 90 Days After Hospital Discharge
Proportion of patients experiencing at least one lower respiratory tract infection event within 90 days after hospital discharge. Events include recurrence of multidrug-resistant bacterial pneumonia, new-onset pneumonia, acute bronchitis, or acute exacerbation of chronic airway disease complicated by lower respiratory tract infection. Events will be assessed based on clinical symptoms and signs, inflammatory biomarkers, chest imaging, and microbiological findings.
From hospital discharge to 90 days after discharge
All-Cause and Pneumonia-Related Mortality
During hospitalization (assessed at discharge or death), and at 30 and 90 days after hospital discharge.
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.
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.
Hospitalized adults with clinically diagnosed pneumonia and microbiologically confirmed multidrug-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. Multidrug-resistant bacterial pneumonia will be defined as pneumonia in which at least one bacterial isolate demonstrates acquired non-susceptibility to at least one antimicrobial agent in each of three or more antimicrobial categories, as determined by standard antimicrobial susceptibility testing. The isolate must be considered a causative pathogen of the current pneumonia episode rather than colonization or contamination, based on clinical manifestations, imaging findings, microbiological results, and the available clinical course.
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000, China
Serum, plasma, and peripheral blood mononuclear cells (PBMCs) will be collected and retained from enrolled participants. These biospecimens may be used for biomarker, inflammatory, immunological, microbiological, and omics-related analyses associated with drug-resistant bacterial pneumonia, treatment response, recurrence of lower respiratory tract infection, prognosis, and safety. PBMCs contain cellular DNA and may be used for DNA extraction when permitted by the approved protocol and informed consent. All retained biospecimens will be stored using coded identifiers and managed according to institutional biospecimen storage and ethics requirements.
Jiansheng Li, Doctor
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
First Submitted
July 7, 2026
First Posted
July 24, 2026
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 30, 2027
EstimatedAll-Cause and Pneumonia-Related Rehospitalization
At 30 and 90 days after hospital discharge.
Incidence of Upper Respiratory Tract Infection Events
From hospital discharge to 90 days after discharge (assessed at days 30 and 90).
Bacterial Clearance Rate
At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).
Clinical Cure Rate at Hospital Discharge
At discharge from the initial hospitalization (up to 90 days after enrollment)
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 30, 2026
Record last verified: 2026-10
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