Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)
研究概览
简要总结
Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).
详细描述
The study will investigate whether - with the current dosing regimens of meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cephazolin, vancomycin, amikacin, teicoplanin and ciprofloxacin - pharmacodynamic targets are attained in a national multicentric clinical setting in pediatric patients on ECMO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted to the pediatric intensive care unit or cardiac intensive care unit
- •patient age : 1,8 kg-15 years
- •patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin)
- •intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)
- •extracorporeal membrane oxygenation circuit
排除标准
- •no catheter in place for blood sampling
- •absence of parental/patient consent
- •known hypersensitivity to beta-lactam antibiotics and ciprofloxacin
结局指标
主要结局
Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)
时间窗: up to 1 month
% of patients for whom a fAUC/MIC target\>86 is achieved with the current dosing regimen off extracorporeal membrane oxygenation in steady-state conditions
for amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)
时间窗: up to 1 month
% of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
Amoxicillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
时间窗: up to 1 month
% of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
Amoxicillin, piperacillin, meropenem, cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
时间窗: up to 1 month
% of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)
时间窗: up to 1 month
% of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
for teicoplanin: probability of target attainment with the target being an Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration Ratio (AUC/MIC)
时间窗: up to 1 month
% of patients in whom an AUC/MIC of 900 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions
Teicoplanin: probability of target attainment with the target being a mimimal trough concentration
时间窗: up to 1 month
% of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
时间窗: up to 1 month
% of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
时间窗: up to 1 month
% of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
时间窗: up to 1 month
% of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
时间窗: up to 1 month
% of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)
时间窗: July 2026
% of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
次要结局
- Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin(up to 1 month)
- Beta-lactam antibiotics (amoxicillin, piperacillin, meropenem, cefazolin): probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC)(up to 1 month)
- Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics(up to 1 month)
- Teicoplanin: probability of target attainment with the target being a mimimal trough concentration(up to 1 month)
- Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin(up to 1 month)
- Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)(up to 1 month)
- Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)(up to 1 month)
- Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin(up to 1 month)
- Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin(up to 1 month)
- Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)(up to 1 month)
- Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration(up to 1 month)