Status:
NOT_YET_RECRUITING
A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections
Lead Sponsor:
Henan University of Traditional Chinese Medicine
Collaborating Sponsors:
Henan Provincial Hospital of TCM
Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Conditions:
Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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-negativ...
Detailed Description
This study evaluates the efficacy and safety of Feireqing Granules for MDR-GNB severe pneumonia through a multicenter, randomized, double-blind, placebo-controlled trial. Key elements of the trial in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT07206745
Start Date
October 1 2025
End Date
December 31 2027
Last Update
October 3 2025
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