Multi Drug Resistant InfectionsMDRBP-TCMNCT07726095
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
An observational study of Multi Drug Resistant Infections and Pneumnia, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi Drug Resistant Infections, Pneumnia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 652 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Zhenzhen Feng, Doctor, +86 15890658268, huxifzz@163.com
About this study
Official title: A Multicenter Prospective Observational Cohort Study of Traditional Chinese Medicine Treatment in Multidrug-Resistant Bacterial Pneumonia
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.
Read the detailed description
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.
- Conditions
- Multi Drug Resistant Infections, Pneumnia
- Keywords
- Drug-resistant bacteria, Traditional Chinese medicine, Prospective cohort, Lower respiratory tract infection, Hospital-acquired pneumonia, Ventilator-associated pneumonia, Community-acquired pneumonia, Antimicrobial resistance, Rehospitalization
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine Cohort | 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. | |
| Non-Systemic Traditional Chinese Medicine Cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital discharge to 90 days after discharge
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At enrollment, discharge (up to 90 days after enrollment), and 30, and 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi Drug Resistant InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 652 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, Doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726095
- Sponsor's protocol ID
- TCM for MDRBP
- Acronym
- MDRBP-TCM
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Cohort Study of Traditional Chinese Medicine Treatment in Multidrug-Resistant Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT07726095
- Acronym / sponsor ID
- MDRBP-TCM / TCM for MDRBP
- Conditions
- Multi Drug Resistant Infections, Pneumnia
- Keywords
- Drug-resistant bacteria, Traditional Chinese medicine, Prospective cohort, Lower respiratory tract infection, Hospital-acquired pneumonia, Ventilator-associated pneumonia, Community-acquired pneumonia, Antimicrobial resistance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 652 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine Cohort | – | –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. |
| Non-Systemic Traditional Chinese Medicine Cohort | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Lower Respiratory Tract Infection Events Within 90 Days After Hospital Discharge
Time frame: From hospital discharge to 90 days after 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.
9 secondary outcomes
All-Cause and Pneumonia-Related Mortality
Time frame: During hospitalization (assessed at discharge or death), and at 30 and 90 days after hospital discharge.
All-Cause and Pneumonia-Related Rehospitalization
Time frame: At 30 and 90 days after hospital discharge.
Incidence of Upper Respiratory Tract Infection Events
Time frame: From hospital discharge to 90 days after discharge (assessed at days 30 and 90).
Bacterial Clearance Rate
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
Time frame: At discharge from the initial hospitalization (up to 90 days after enrollment)
Duration of Systemic Antibacterial Therapy
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
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
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
Time frame: At enrollment, discharge (up to 90 days after enrollment), and 30, and 90 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiansheng Li, Doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi Drug Resistant Infections and Pneumnia, run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Feng, Doctor (+86 15890658268, huxifzz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Lower Respiratory Tract Infection Events Within 90 Days After Hospital Discharge (time frame: From hospital discharge to 90 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.