Observed Pharmacokinetic of Piperacillin/Tazobactam in ICU Patients Compared to Therapeutic Drug Monitoring of Amikacin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in plasma concentration of amikacin during the first 24 hours after administration
研究概览
简要总结
The pharmacokinetics of antimicrobials is profoundly modified in Intensive care unit (ICU) patients. To adapt the treatment, it is recommended to measure blood levels of antibiotics. Some antibiotics, such as amikacin, are easy to monitor, while for other molecules, such as piperacillin/tazobactam, the drug monitoring is more difficult to obtain. These two molecules have similar physicochemical characteristics (hydrophilicity) and therefore have closed pharmacokinetic properties. OPTIMA is a study aiming at criteria will be used to judge whether the pharmacokinetic (PK) parameters of amikacin are predictive of those of piperacillin and tazobactam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient ≥ 18 years old
- •Patient hospitalized in the critical care department of the Lyon-Sud hospital centre
- •Patient with a sepsis or a severe sepsis table defined by the latest international recommendations
- •Patient to be treated by the amikacin + piperacillin/tazobactam association
- •Patient affiliated to a social security system, having agreed to participate in the study
排除标准
- •Patient with a known history of hypersensitivity or contraindication to amikacin, piperacillin or tazobactam
- •Patient known to have previously received piperacillin/tazobactam or amikacin combination before inclusion
- •Patient treated at the time of inclusion with dialysis techniques
结局指标
主要结局
Change in plasma concentration of amikacin during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Change in plasma concentration of piperacillin during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Change in plasma concentration of tazobactam during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Dose administered of amikacin at baseline
时间窗: Hour 0 (Baseline)
Dose administered of piperacillin at baseline
时间窗: Hour 0 (Baseline)
Dose administered of tazobactam at baseline
时间窗: Hour 0 (Baseline)
Change in plasma volume of distribution of amikacin during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered
Change in plasma volume of distribution of piperacillin during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered
Change in plasma volume of distribution of tazobactam during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered
Change in plasma clearance of amikacin during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered
Change in plasma clearance of piperacillin during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered
Change in plasma clearance of tazobactam during the first 24 hours after administration
时间窗: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered
次要结局
未报告次要终点