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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Test group
The patients in the trial group received routine standard treatments, and oral Fei Re Qing Granules (One bag/time, 3 times/day).
干预措施: Fei Re Qing Granules (Drug)
Control group
The patients in the control group received routine standard treatments, and Placebo granules
干预措施: Placebo of Feireqing Granules (Drug)
结局指标
主要结局
All-cause mortality
时间窗: All-cause mortality: assessed at 14 and 28 days post-enrollment.
All-cause mortality will be assessed as the proportion of participants who die from any cause during the study period. Mortality will be recorded at Day 14 and Day 28 after enrollment.
次要结局
- Clinical cure rate(Evaluations will be conducted on treatment Day 0, Day 14 and during follow-up on Day 28.)
- Bacterial clearance rate(Treatment days 0, days 7, and days 14.)
- Duration of antibiotic use(From Day 0 of treatment to Day 28 of follow-up)
- Invasive mechanical ventilation rate(From Day 0 of treatment to Day 28 of follow-up)
- Length of hospital stay(From Day 0 of treatment to Day 28 of follow-up)
- Clinical Pulmonary Infection Score (CPIS)(Assessed on treatment days 0, 7, and 14, and on follow-up days 14 and 28.)
- SOFA score(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(From Day 0 of treatment to Day 28 of follow-up)