Recruiting
Not applicable
A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections
Condition(s) studied
Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection
Investigational drug(s) / intervention(s)
Fei Re Qing GranulesPlacebo of Feireqing Granules
Fei Re Qing Granules: Fei 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: Placebo 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.
Study summary
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
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* Patients with hematologic malignancies, solid organ transplantation, or congenital/acquired diseases leading to immunodeficiency;
* Patients with multidrug-resistant bacterial infections outside the lung (e.g., urinary tract, abdominal cavity, bloodstream);
* Patients with severe cardiac dysfunction (NYHA class IV), malignant arrhythmias, or other hemodynamically unstable conditions;
* Patients who have already received antimicrobial therapy for more than one week;
* Patients who have participated in another drug clinical trial within one month prior to enrollment;
* Patients with known allergy to the investigational drug.
Primary outcome measure(s)
- All-cause mortality — All-cause mortality: assessed at 14 and 28 days post-enrollment.
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| First Affiliated Hospital of Henan University of Traditional Chinese Medicine |
Zhengzhou |
Henan |
Recruiting |
More Henan University of Traditional Chinese Medicine trials in China