Antibiotic Dosing in Pediatric Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
研究概览
简要总结
Pharmacokinetics of antibiotics in critically ill neonates, infants and children
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 16 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
- •patient age/weight : 1,8 kg-15 years
- •patient receiving antibiotic treatment (piperacillin-tazobactam, amoxicillin-clavulanate, vancomycin, teicoplanin, meropenem, ciprofloxacin, amikacin) via intermittent infusion regimen or continuous infusion according to institutional treatment guidelines
- •intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)
排除标准
- •no catheter in place for blood sampling
- •absence of parental/patient consent
- •known hypersensitivity to beta-lactam antibiotics, glycopeptides, fluoroquinolones, aminoglycosides
- •extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )
研究组 & 干预措施
amoxicillin-clavulanate
Patients receiving amoxicillin-clavulanate as part of routine clinical care.
干预措施: blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care (Procedure)
piperacilline-tazobactam
Patients receiving piperacilline-tazobactam as part of routine clinical care.
干预措施: blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care. (Procedure)
vancomycin
Patients receiving vancomycin as part of routine clinical care.
干预措施: blood sampling in patients receiving vancomycin as part of routine clinical care. (Procedure)
teicoplanin
Patients receiving teicoplanin as part of routine clinical care.
干预措施: blood sampling in patients receiving teicoplanin as part of routine clinical care. (Procedure)
meropenem
Patients receiving meropenem as part of routine clinical care.
干预措施: blood sampling in patients receiving meropenem as part of routine clinical care. (Procedure)
ciprofloxacin
Patients receiving ciprofloxacin as part of routine clinical care.
干预措施: blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care. (Procedure)
amikacin
Patients receiving amikcain as part of routine clinical care.
干预措施: blood sampling in patients receiving amikacin as part of routine clinical care. (Procedure)
结局指标
主要结局
To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
时间窗: 2 years (expected)
To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
时间窗: 2 years (expected)
次要结局
- To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC)(2 years (expected))
- To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC)(2 years (expected))