NCT03409679终止3 期
A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
Polyphor Ltd.9 个研究点 分布在 6 个国家目标入组 41 人开始时间: 2018年3月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 9
- 主要终点
- Clinical cure rate
研究概览
简要总结
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has received mechanical ventilation for at least 48h at the time of the randomisation
- •Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization
- •Presence of new or progressive infiltrate on chest X-ray
- •Presence of clinical criteria consistent with VABP
- •High probability of VABP caused by Pseudomonas aeriginosa
排除标准
- •Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
- •Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction
- •Severe liver or renal impairment
- •Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control
研究组 & 干预措施
Two anti-pseudomonal antibiotics
Active Comparator
Association of 2 anti-pseudomonal antibiotics
干预措施: Two anti-pseudomonal antibiotics (Drug)
Murepavadin
Experimental
Murepavadin IV + one anti-pseudomonal antibiotic
干预措施: Murepavadin (Drug)
结局指标
主要结局
Clinical cure rate
时间窗: 21-24 days after start of study treatment
次要结局
未报告次要终点
研究者
研究点 (9)
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