NCT03582007终止3 期
A Multicenter, Open Label, Sponsor Blinded, Randomized, Active Controlled, Parallel Group, Pivotal Study to Evaluate the Efficacy, Safety, and Tolerability of Murepavadin Given With Ertapenem Versus an Anti-pseudomonal-β-lactam-based Antibiotic in Adult Subjects With Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
Polyphor Ltd.2 个研究点 分布在 2 个国家目标入组 2 人开始时间: 2018年10月22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
- 2
- 试验地点
- 2
- 主要终点
- All cause mortality rates
研究概览
简要总结
This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia 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
- Single (Outcomes Assessor)
盲法说明
Sponsor blinded
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 OR at least 2 of the following signs or symptoms presenting within 24 hours prior to randomization: New onset of cough or worsening of baseline cough and/or dyspnea, tachypnea and/or hypoxemia and/or new onset of sputum or suctioned respiratory secretion characterized by purulent appearance indicative of bacterial infection or a worsening in character of purulent appearance
- •Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 25, inclusive, within 24h prior to randomization
- •Presence of new or progressive infiltrate on chest X-ray
- •Presence of clinical criteria consistent with Pneumonia
- •Strong clinical suspicion of pneumonia due to P. aeruginosa
排除标准
- •Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
- •known hypersensitivity to any component of ertapenem, meropenem or to other drugs in the same class or demonstrated anaphylactic reactions to beta-lactams or a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors
- •Severe liver or renal impairment
- •Expected survival < 72 hours
- •Evidence from an available surveillance culture of co infection with ertapenem , meropenem or piperacillin tazobactam resistant Gram negative pathogen(s)
- •Women who are pregnant or nursing
研究组 & 干预措施
Murepavadin
Experimental
Murepavadin + ertapenem
干预措施: Murepavadin (Drug)
Anti-pseudomonal antibiotic
Active Comparator
One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam)
干预措施: One anti-pseudomonal antibiotic (Drug)
结局指标
主要结局
All cause mortality rates
时间窗: 28 days after start of study treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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