Multiple-dose Pharmacokinetics of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid During Haemodialysis in Longterm Haemodialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels.
研究概览
简要总结
The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and amoxicillin/clavulanic acid during intermittent haemodialysis.
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
- •Age >18 years
- •Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- •Renal replacement therapy (HD)
排除标准
- •Known hypersensitivity to ampicillin / sulbactam, amoxicillin / clavulanic acid or other beta-lactames, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- •An expected survival of less than two days.
- •Known pregnancy
- •Co-administration of one of the following drugs: probenecid which cannot be discontinued for the duration of the study
- •Ampicillin / sulbactam respectively amoxicillin / clavulanic acid as monotherapy for resistant species or fungal infections.
- •Other reasons opposing the study participation on the discretion of the investigators.
研究组 & 干预措施
Ampicillin / sulbactam
Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
干预措施: Ampicillin / sulbactam (Drug)
Ampicillin / sulbactam
Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
干预措施: Blooddraws for pharmacokinetic profiling (Procedure)
Amoxicillin / clavulanic acid
Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
干预措施: Administration of Amoxicillin / clavulanic acid (Drug)
Amoxicillin / clavulanic acid
Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
干预措施: Blooddraws for pharmacokinetic profiling (Procedure)
结局指标
主要结局
Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid 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
a.o.Univ.-Prof. Dr.
Medical University of Vienna