A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection
In brief
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.
Key facts
- Study ID
- NCT07206745
- Run by
- Henan University of Traditional Chinese Medicine
- People needed
- 152
- Starts
- 2025-12-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Zhengzhou, Henan, China (enrolling)
Full record on ClinicalTrials.gov
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