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
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