NCT02007122Unknown4 期
Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.
研究概览
简要总结
The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.
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
- 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
- •Age >18 years, able to give written informed consent
- •Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- •Renal replacement therapy (continuous or intermittent)
排除标准
- •Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- •An expected survival of less than two days.
- •Known pregnancy
- •Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
- •Ceftaroline as monotherapy for resistent species or fungal infections.
- •Other reasons oposing the study participation on the discretion of the investigators
结局指标
主要结局
Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.
时间窗: day 15
Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.
次要结局
未报告次要终点
研究者
Florian Thalhammer
Univ.-Prof. Dr.
Medical University of Vienna
研究点 (2)
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