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.
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.
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;
Parallel
Fei Re Qing Granules
DrugFei Re Qing Granules (Ingredients: Scutellaria baicalensis \[Huang Qin\], Trichosanthes kirilowii \[Gua Lou\], Forsythia suspensa \[Lian Qiao\], Fritillaria thunbergii \[Zhe Bei Mu\], etc.). Routine standard treatments：Routine standard treatments according to clinical guidelines.
Placebo of Feireqing Granules
DrugPlacebo of Feireqing Granules：The placebo granules are prepared using 5% of the active drug combined with pharmaceutical excipients, including starch, dextrin, microcrystalline cellulose, and food-grade coloring and flavoring agents, to ensure consistency in appearance, weight, color, and odor with the Fei Re Qing Granules. Routine standard treatments：Routine standard treatments according to clinical guidelines.
All-cause mortality
All-cause mortality will be assessed as the proportion of participants who die from any cause during the study period. Mortality will be recorded at Day 14 and Day 28 after enrollment.
Clinical cure rate
According to the Technical Guidelines for Clinical Trials of Antibacterial Drugs, clinical cure is defined as the complete resolution or normalization of all symptoms and signs present at baseline at the post-treatment visit, along with normalization of non-microbiological indicators such as imaging and laboratory tests. In practice, some clinical symptoms or signs, or abnormalities in non-microbiological indicators, may still be observed at the post-treatment visit. If these findings are physiological, reflect post-infection status, or are related to underlying diseases rather than active infection, they may also be considered indicative of clinical cure.
Bacterial clearance rate
Based on microbiological testing during hospitalization. Pathogen-targeted next-generation sequencing (tNGS) of bronchoalveolar lavage fluid or sputum, or sputum culture, is performed on treatment days 0, 7, and 14 for evaluation.
Duration of antibiotic use
Total number of days of antibiotic therapy during hospitalization, including both intravenous and oral administration.
Invasive mechanical ventilation rate
The invasive mechanical ventilation rate will be assessed as the proportion of participants who require invasive mechanical ventilation during the study period. Eligible participants are those not receiving invasive ventilation at baseline (Day 0). The outcome is defined as the need for endotracheal intubation and mechanical ventilation due to clinical deterioration, including worsening hypoxemia, hypercapnia, or respiratory failure. The rate will be calculated as the number of participants requiring invasive mechanical ventilation divided by the total number of participants at risk, from Day 0 of treatment to Day 28 of follow-up.
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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
