Systemic Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia

NCT07726095 | Not Yet Recruiting DMC

• 1 other identifier: TCM for MDRBP
• Study Type: observational
• Target: 528
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

Outcome Measures

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.

  From hospital discharge to 180 days after discharge

Secondary Outcomes (9)

• Mortality

  At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.

• Rehospitalization

  At 30, 90, and 180 days after discharge

• Upper Respiratory Tract Infection Events

  From discharge to 180 days after discharge

• Bacterial Clearance

  At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).

• Clinical Cure

  At discharge from the initial hospitalization (up to 90 days after enrollment)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections

Study Officials

• Jiansheng Li, Doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Zhenzhen Feng, Doctor

CONTACT

+86 15890658268; huxifzz@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

CN (1)