Feireqing Granules added to standard care for severe pneumonia from resistant Gram-negative infections
Official title: Efficacy Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections: A Randomized, Double-Blind, Placebo-Controlled Trial
Run by Henan University of Traditional Chinese Medicine · NCT07206745 · Data updated 2026-11-12
This trial tests whether Feireqing Granules, used with standard treatment, can help adults with severe pneumonia caused by drug-resistant Gram-negative bacteria.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 152 (estimated) |
| Sponsor | Henan University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07206745 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to under 80 with severe pneumonia due to MDR Gram-negative infections confirmed by culture and meeting study criteria.
✕Probably not a fit
Patients without MDR-GNB pneumonia, with non-severe pneumonia, or with contraindications to the study medication may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled study compares Feireqing Granules plus standard modern care to placebo granules plus standard care in adults with MDR-GNB severe pneumonia. Participants receive treatment for 14 days and are followed for 28 days to assess outcomes. The primary outcome is all-cause mortality, with secondary outcomes including clinical cure, bacterial clearance, duration of antibiotics, ventilation needs, hospital stay, CPIS, and APACHE II and SOFA scores. The trial is sponsored by Henan University of Traditional Chinese Medicine and conducted at select Henan facilities.
Why it matters
Potential benefit: If successful, Feireqing Granules could become an adjunct therapy to reduce mortality and improve recovery in MDR-GNB severe pneumonia.
How similar studies have gone: Prior studies in traditional Chinese medicine for severe pneumonia are mixed; this trial tests a specific granule formulation with rigorous randomized design.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China Recruiting
Study contacts
- Study coordinator: Zhenzhen Feng, Doctor
- Email: huxifzz@163.com
- Phone: +86 15890658268
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.