A Randomized Controlled Trial of Bacteriophage Cocktail Therapy for Multidrug-Resistant Gram-Negative Ventilator-Associated Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 248
- 主要终点
- Clinical response rate
研究概览
简要总结
The purpose of this study is to systematically evaluate the efficacy and safety of bacteriophage cocktail therapy in patients with ventilator-associated pneumonia caused by Gram-negative bacterial infections.
详细描述
This study investigates the clinical application of bacteriophage therapy in severe infections through a prospective, randomized, multi-center trial targeting ventilator-associated pneumonia (VAP) caused by multidrug-resistant Gram-negative bacteria. The trial will comprehensively assess the efficacy, safety, and applicability of inhaled bacteriophage cocktail therapy, providing high-quality clinical evidence to support the establishment of an evidence-based framework for phage therapy. The primary endpoint is clinical response rate, with secondary endpoints including bacterial clearance and 28-day mortality, aiming to determine the therapeutic potential and clinical value of phage cocktails in VAP treatment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ventilator-associated pneumonia (VAP);
- •Identified infection with MDR Klebsiella pneumoniae, Acinetobacter baumannii, or Pseudomonas aeruginosa via MROSE evaluation and antimicrobial susceptibility testing (AST) from this or other tertiary hospitals;
- •Aged 18 to 85 years;
- •Written informed consent obtained from the patient or legal guardian.
排除标准
- •Pregnant or breastfeeding women;
- •FiO₂ ≥ 70% or PEEP ≥ 15 cmH₂O;
- •Hemodynamic instability (vasopressor dose increased by ≥30% in the last 6 hours or norepinephrine > 0.5 μg/kg/min);
- •Known allergy to phage components.
研究组 & 干预措施
control group
Nebulized normal saline inhalation therapy
干预措施: Nebulized normal saline inhalation therapy (Drug)
phage therapy group
Phage cocktail administered via nebulization
干预措施: Phage cocktail administered via nebulization (Drug)
结局指标
主要结局
Clinical response rate
时间窗: From enrollment to the end of treatment (within 10 days of enrollment)
次要结局
- Bacterial clearance rate(10 days after enrollment)
- 28-day mortality(28 days after enrollment)
- Length of hospital stay(28 days after enrollment)
- Length of invasive mechanical ventilation(28 days after enrollment)
- CPIS score(1，5，10 days after enrollment)
- SOFA score(1，5，10 days after enrollment)
研究者
wang kaifei
Clinical Professor
Chinese PLA General Hospital