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临床试验/NCT01975493
NCT01975493Unknown不适用

Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study

St George's, University of London9 个研究点 分布在 1 个国家目标入组 428 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
428
试验地点
9
主要终点
The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin.

研究概览

简要总结

The aim of NAPPA is to develop new models to improve our understanding of how children process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens used for children in the future. The study population will involve children and neonates who need a penicillin antibiotic as part of their normal National Health Service (NHS) care, and who also need blood tests or intravenous access. Therefore the antibiotic study can be done without the need for any extra invasive procedures, and there will be no change to the medication therapy received by participants. In addition, NAPPA will evaluate whether it is feasible to measure antibiotic levels on a tiny drop of blood put onto absorbent paper ("dried blood spot"). This allows the sample to be stored and tested later on. NAPPA will compare the level of the antibiotic using this method with the level measured in the usual way, to show if this is a reliable method that could be used routinely in the future.

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 Minute 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged under 16 years receiving one of the specified penicillins and with intravenous access or blood test(s) as part of their routine clinical care.
  • Informed consent form signed by parent or legal guardian.

排除标准

  • Any child or infant unlikely to survive 48 hours after recruitment.
  • Patient known to be pregnant.
  • Known allergy or hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins) or beta-lactamase inhibitors.
  • Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass.

结局指标

主要结局

The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin.

时间窗: Participants will be followed for the duration of enrolment, an expected average of 7 days.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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