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A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections

RecruitingNAAges 18 Years - 80 YearsAllHenan University of Traditional Chinese Medicine
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Meeting the diagnostic criteria for severe pneumonia, aged โ‰ฅ18 years and \<80 years; * Microbiological culture confirming Gram-negative bacterial infection resistant to three or more classes of antibiotics, such as extended-spectrum ฮฒ-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 mยฒ; * 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.
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What it tests

  • Fei Re Qing Granules
  • Placebo of Feireqing Granules
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Where

1 site
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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