A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHenan University of Traditional Chinese Medicine

About this trial

This study aims to evaluate the clinical efficacy of a traditional Chinese medicine formula granule (Feireqing Granules) in the treatment of severe pneumonia caused by multidrug-resistant Gram-negative bacterial infections (MDR-GNB severe pneumonia), to establish a therapeutic regimen, and to generate high-quality clinical evidence.

Eligibility criteria

Qualifiers

Meeting the diagnostic criteria for severe pneumonia, aged ≥18 years and <80 years;

Microbiological culture confirming Gram-negative bacterial infection resistant to three or more classes of antibiotics, such as extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii (CRAB), and multidrug-resistant Pseudomonas aeruginosa (MDR-PA);

Written informed consent obtained from the patient or their legal representative.

Disqualifiers

Pregnant or breastfeeding women;

Patients with impaired consciousness, dementia, psychiatric disorders, or other conditions that preclude effective communication and cooperation;

Patients with aspiration pneumonia, fungal pneumonia, viral pneumonia, pulmonary tuberculosis, or HIV-associated Pneumocystis jirovecii pneumonia;

Patients with severe hepatic or renal insufficiency, such as liver cirrhosis with Child-Pugh score of 10-15, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²;

Trial design

Treatments tested in this trial

  • Fei Re Qing Granules
  • Placebo of Feireqing Granules

Treatment groups

152 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Henan University of Traditional Chinese Medicine

Lead sponsor

Henan Provincial Hospital of TCM

Collaborator

Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborator

Henan Provincial People's Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborator