NCT07206745

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 include: Design: Conducted across multiple centers, comparing Feireqing Granules and placebo groups, alongside standard guideline-based modern medical treatment. Participants: Patients diagnosed with MDR-GNB severe pneumonia according to modern medical diagnostic criteria, aged ≥18 years and \<80 years. 76 patients will be enrolled in each group. Intervention: Test group: Participants will receive Feireqing Granules in combination with standard modern medical treatments. Control group: Participants will receive placebo granules (matching the appearance, weight, color, and odor of the active granules, composed mainly of starch, dextrin, microcrystalline cellulose, and 5% active drug) in combination with standard modern medical treatments. Outcomes: Primary efficacy indicator: All-cause mortality. Secondary indicators: Clinical cure rate, bacterial clearance rate, duration of antibiotic therapy, effective mechanical ventilation rate, length of hospital stay, Clinical Pulmonary Infection Score (CPIS), Acute Physiology and Chronic Health Evaluation II (APACHE II) score, and Sequential Organ Failure Assessment (SOFA) score. Study Duration: Treatment for 14 days, with a 28-day follow-up. This trial seeks to confirm the clinical efficacy of Feireqing Granules in treating MDR-GNB severe pneumonia and to provide high-quality evidence for the long-term and objective evaluation of TCM interventions.

Conditions

• Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection

Interventions

Type	Name	Description
DRUG	Fei Re Qing Granules	Fei Re Qing Granules (Ingredients: Scutellaria baicalensis \[Huang Qin\], Trichosanthes kirilowii \[Gua Lou\], Forsythia suspensa \[Lian Qiao\], Fritillaria thunbergii \[Zhe Bei Mu\], etc.). Routine standard treatments：Routine standard treatments according to clinical guidelines.
DRUG	Placebo of Feireqing Granules	Placebo of Feireqing Granules：The placebo granules are prepared using 5% of the active drug combined with pharmaceutical excipients, including starch, dextrin, microcrystalline cellulose, and food-grade coloring and flavoring agents, to ensure consistency in appearance, weight, color, and odor with the Fei Re Qing Granules. Routine standard treatments：Routine standard treatments according to clinical guidelines.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2025-10-03
• Last updated: 2025-10-03