NCT00318994已完成4 期
Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 and 60 minutes after a bolus of 1 g IV meropenem applied during induction of anesthesia.
研究概览
简要总结
To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the induction period of anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with diagnosis of severe pancreatitis requiring surgery according to the protocol of each Institution.
- •Informed consent signed by the subject
- •Subjects who have received prophylactic antibiotics for previous invasive procedures different from surgery may be included
排除标准
- •Will of the subject not to be included
- •Subjects who have not signed the informed consent
- •Subjects with known hypersensibility to carbapenems, penicillins, or cephalosporins
结局指标
主要结局
To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 and 60 minutes after a bolus of 1 g IV meropenem applied during induction of anesthesia.
次要结局
- To describe the incidence of infectious complications during the first 30 days after surgery in subjects with severe pancreatitis receiving IV meropenem at a dose of 1 g every 8 hours during 14 days.
研究者
研究点 (2)
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