NCT01853982终止3 期
A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam With That of Piperacillin/Tazobactam in Ventilator Associated Pneumonia
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)0 个研究点目标入组 4 人开始时间: 2013年6月14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
- 4
- 主要终点
- Clinical Response at the End of Therapy Visit
研究概览
简要总结
This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants .
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
- •Participant has received mechanical ventilation for > 48 hours
- •Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35
- •Presence of a new or progressive infiltrate on chest x-ray
- •Presence of clinical criteria consistent with VAP
排除标准
- •History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
- •Known end stage renal disease or requirement for dialysis
研究组 & 干预措施
Ceftolozane/Tazobactam
Experimental
3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
干预措施: Ceftolozane/Tazobactam (Drug)
Piperacillin/Tazobactam
Active Comparator
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
干预措施: Piperacillin/Tazobactam (Drug)
结局指标
主要结局
Clinical Response at the End of Therapy Visit
时间窗: 24 hours after last dose of study drug
次要结局
未报告次要终点
研究者
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