An observational study in Multi Drug Resistant Infections and Pneumnia, sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Henan University of Traditional Chinese Medicine · Observational
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.
Multidrug-resistant (MDR) bacterial pneumonia remains a major clinical challenge because of limited effective antimicrobial options, increased risks of treatment failure and recurrent respiratory infections, and prolonged antimicrobial exposure. Traditional Chinese medicine (TCM) is commonly used as an adjunct to conventional treatment in China. However, prospective real-world evidence regarding the association between systemic TCM treatment and clinical outcomes in patients with MDR bacterial pneumonia remains limited.
This multicenter prospective observational cohort study will enroll hospitalized adult patients with MDR bacterial pneumonia. All treatment decisions, including antimicrobial therapy, supportive care, and TCM use, will be made by the treating physicians according to routine clinical practice. The study will not assign, mandate, or modify any treatment. Patients will be classified according to whether they receive systemic TCM treatment during hospitalization. Systemic TCM treatment includes Chinese herbal decoctions, oral Chinese patent medicines, and Chinese medicine injections. Other TCM therapies will be recorded separately but will not determine cohort allocation.
Clinical characteristics, microbiological findings, treatment exposure, and clinical outcomes will be prospectively documented during hospitalization and follow-up. Particular attention will be given to lower respiratory tract infection events within 90 days after hospital discharge, as well as clinical recovery, antimicrobial use, and subsequent patient outcomes. The analysis will consider potential differences in baseline characteristics and clinical severity between the exposed and unexposed cohorts.
This study aims to provide real-world evidence on the association between systemic TCM treatment and clinical outcomes in patients with MDR bacterial pneumonia and to inform future research on the potential role of TCM as an adjunct to conventional care.
121 studies on the registry are indexed under Healthcare-Associated Pneumonia; 22 are open to participants now.
This study's planned enrollment of 652 is above the median of 310 across 39 observational studies indexed under Healthcare-Associated Pneumonia.
Browse Healthcare-Associated Pneumonia studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 55 studies on the registry; 31 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: From hospital discharge to 90 days after discharge
All-Cause and Pneumonia-Related Mortality
Number and proportion of participants who die from any cause or pneumonia-related causes during hospitalization and follow-up. All-cause mortality is defined as death from any cause. Pneumonia-related mortality is defined as death attributable to pneumonia, pneumonia progression, or pneumonia-related complications. All-cause and pneumonia-related mortality will be assessed separately.
Time frame: During hospitalization (assessed at discharge or death), and at 30 and 90 days after hospital discharge.
All-Cause and Pneumonia-Related Rehospitalization
Number and proportion of participants rehospitalized for any cause or pneumonia-related reasons within 90 days after hospital discharge. All-cause rehospitalization is defined as hospital readmission for any reason. Pneumonia-related rehospitalization is defined as readmission due to pneumonia recurrence, a new pulmonary infection, or worsening of the original pneumonia. All-cause and pneumonia-related rehospitalization will be assessed separately.
Time frame: At 30 and 90 days after hospital discharge.
Incidence of Upper Respiratory Tract Infection Events
Number and proportion of participants experiencing at least one upper respiratory tract infection event within 90 days after hospital discharge. Events include common cold, acute viral pharyngitis, and laryngitis. For each event, the duration, microbiological findings, associated rehospitalization, medications used, and related medical costs will be recorded.
Time frame: From hospital discharge to 90 days after discharge (assessed at days 30 and 90).
Bacterial Clearance Rate
Number and proportion of participants with confirmed or presumed clearance of the target causative pathogen. Confirmed clearance is defined as the absence of the target pathogen on repeat microbiological testing after treatment. Presumed clearance is defined as marked clinical improvement without evidence of infection progression or recurrence when repeat microbiological testing is not performed. Assessment will be based on microbiological findings obtained at diagnosis, hospital discharge, or when the patient's clinical condition changes, as available.
Time frame: At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).
Clinical Cure Rate at Hospital Discharge
Number and proportion of participants achieving clinical cure at hospital discharge. Clinical cure is defined as resolution of pneumonia-related symptoms and signs or return to pre-infection status, normalization of non-microbiological laboratory indicators, complete or partial radiographic resolution of pulmonary inflammatory changes, and no further need for antibacterial therapy targeting the index pneumonia. Clinical outcomes will be classified as clinical cure, clinical failure, or indeterminate.
Time frame: At discharge from the initial hospitalization (up to 90 days after enrollment)
Duration of Systemic Antibacterial Therapy
Total number of days of systemic antibacterial therapy from enrollment to hospital discharge or completion of treatment. Each calendar day on which at least one systemic antibacterial agent is administered will be counted as one antibacterial treatment day, regardless of the number of agents used. Agent-specific days of therapy will be calculated separately for combination treatment. Antibacterial drug types, doses, routes of administration, treatment duration, combination therapy, treatment escalation or de-escalation, and days of broad-spectrum or special-grade antibacterial use will also be recorded.
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
Pneumonia-related clinical status will be assessed using the Modified Community-Acquired Pneumonia Clinician-Reported Outcome Scale. The scale contains 11 clinician-reported items evaluating pneumonia-related symptoms and signs during the previous 24 hours and the clinician's overall assessment of disease improvement. Each item is scored from 0 to 4, and the item scores are summed to produce a total score ranging from 0 to 44. Higher scores indicate more severe pneumonia-related symptoms and signs and less clinical improvement.
Time frame: At enrollment, hospital discharge(up to 90 days after enrollment), and 30 and 90 days after hospital discharge.
Modified Community-Acquired Pneumonia Patient-Reported Outcome Score
Pneumonia-related symptoms and patient-perceived health status will be assessed using the Modified Community-Acquired Pneumonia Patient-Reported Outcome Scale. The scale contains 17 patient-reported items evaluating pneumonia-related symptoms during the previous 24 hours, the effects of the illness on daily activities and work or study, and satisfaction with health status and treatment effectiveness. Each item is scored from 0 to 4, and the item scores are summed to produce a total score ranging from 0 to 68. Higher scores indicate more severe pneumonia-related symptoms, greater impairment in daily functioning, and lower satisfaction with health status and treatment effectiveness.
Time frame: At enrollment, discharge(up to 90 days after enrollment), and 30, and 90 days after discharge
36-Item Short Form Health Survey Score
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey. The instrument evaluates eight health domains. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: At enrollment, discharge (up to 90 days after enrollment), and 30, and 90 days after discharge
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 20 observational studies under Healthcare-Associated Pneumonia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 75. This study's planned 12 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Dec 2026, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Healthcare-Associated Pneumonia →
Henan University of Traditional Chinese Medicine