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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
528 Participants
are grouped into 2 trial groupsGroup A: Traditional Chinese Medicine Cohort
Group B: Non-Systemic Traditional Chinese Medicine Cohort
Trial outcomes
Primary outcomes
1
Time to First Lower Respiratory Tract Infection Event
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.
Time frame
From hospital discharge to 180 days after dischargeSecondary outcomes
1
Mortality
Number and proportion of participants who die during hospitalization or follow-up.
Time frame
At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.2
Rehospitalization
Number and proportion of participants who are rehospitalized after discharge.
Time frame
At 30, 90, and 180 days after discharge3
Upper Respiratory Tract Infection Events
Number and proportion of participants with upper respiratory tract infection events, including common cold, acute viral pharyngitis, or laryngitis.
Time frame
From discharge to 180 days after discharge4
Bacterial Clearance
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.
Time frame
At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).Sponsors and contacts
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Source ClinicalTrials.gov
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