Systemic Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan University of Traditional Chinese Medicine

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

528 Participants
are grouped into 2 trial groups