Antibiotic Dosing in Patients on Intermittent Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin
研究概览
简要总结
The adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating pharmacokinetics-pharmacodynamics (PK-PD) target attainment. A population pharmacokinetic study is performed to assist the selection of the optimal individualized dose for patients undergoing intermittent dialysis, taking into consideration as many relevant variables as possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients with end-stage kidney disease, requiring intermittent hemodialysis
- •patient receiving antibiotic treatment for documented or presumed infection (vancomycin, teicoplanin, amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim)
排除标准
- •pregnant woman
- •absence of written informed consent from the patient
- •known hypersensitivity or contra-indication to glycopeptides or beta-lactam antibiotics
结局指标
主要结局
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin
时间窗: 9/2016 - 12/2021
Measured free and total concentration of the glycopeptide vancomycin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be \>=400 for vancomycin.
Pharmacokinetics of amoxicillin-clavulanic acid in patients undergoing intermittent hemodialysis
时间窗: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured amoxicillin-clavulanic acid concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured amoxicillin-clavulanic acid concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for teicoplanin
时间窗: 9/2016 - 12/2021
Measured free and total concentration of the glycopeptide teicoplanin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be \>=750 for teicoplanin.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for piperacillin-tazobactam
时间窗: 9/2016 - 12/2021
Measured concentration of the beta-lactam piperacillin-tazobactam is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Pharmacokinetics of piperacillin-tazobactam in patients undergoing intermittent hemodialysis
时间窗: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured piperacillin-tazobactam concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured piperacillin-tazobactam concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for amoxicillin-clavulanic acid
时间窗: 9/2016 - 12/2021
Measured concentration of the beta-lactam amoxicillin-clavulanic acid is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for ceftazidim
时间窗: 9/2016 - 12/2021
Measured concentration of the beta-lactam ceftazidim is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Pharmacokinetics of vancomycin in patients undergoing intermittent hemodialysis
时间窗: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured vancomycin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured vancomycin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Pharmacokinetics of teicoplanin in patients undergoing intermittent hemodialysis
时间窗: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured teicoplanin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured teicoplanin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Pharmacokinetics of ceftazidim in patients undergoing intermittent hemodialysis
时间窗: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured ceftazidim concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured ceftazidim concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
次要结局
- Dialyser extraction rate of vancomycin(9/2016 - 12/2021)
- Dialyser extraction rate of ceftazidim(9/2016 - 12/2021)
- Dialyser extraction rate of amoxicillin-clavulanic acid(9/2016 - 12/2021)
- Dialyser extraction rate of teicoplanin(9/2016 - 12/2021)
- Dialyser extraction rate of piperacillin-tazobactam(9/2016 - 12/2021)