A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resis… (NCT07206745) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections
152 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
What they're measuring
1
All-cause mortality
Timeframe: All-cause mortality: assessed at 14 and 28 days post-enrollment.
Trial details
NCT IDNCT07206745
SponsorHenan University of Traditional Chinese Medicine