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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• All-cause mortality [Срок оценки: All-cause mortality: assessed at 14 and 28 days post-enrollment.]

Вторичные конечные точки (8)

• Clinical cure rate [Срок оценки: Evaluations will be conducted on treatment Day 0, Day 14 and during follow-up on Day 28.]
• Bacterial clearance rate [Срок оценки: Treatment days 0, days 7, and days 14.]
• Duration of antibiotic use [Срок оценки: From Day 0 of treatment to Day 28 of follow-up]
• Invasive mechanical ventilation rate [Срок оценки: From Day 0 of treatment to Day 28 of follow-up]
• Length of hospital stay [Срок оценки: From Day 0 of treatment to Day 28 of follow-up]
• Clinical Pulmonary Infection Score (CPIS) [Срок оценки: Assessed on treatment days 0, 7, and 14, and on follow-up days 14 and 28.]
• SOFA score [Срок оценки: Recorded on treatment days 0, 7, and 14, and on follow-up days 14 and 28.]
• Acute Physiology and Chronic Health Evaluation II (APACHE II) score [Срок оценки: From Day 0 of treatment to Day 28 of follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Чжэнчжоу

Идентификаторы

NCT: NCT07206745 · TCM for MDR-GNB pneumonia

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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