Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,520
- 试验地点
- 52
- 主要终点
- Composite of pharmacokinetic outcomes for understudied drugs in children
研究概览
简要总结
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
详细描述
The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs administered to children per standard of care as prescribed by their treating caregiver. This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver. The prescribing of drugs to children will not be part of this protocol.
Aim #1: Evaluate the PK of understudied drugs currently being administered to children.
Hypothesis #1: The PK of understudied drugs in children will differ from adults and within children according to pediatric age groups or special population.
Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered to children.
Hypothesis #2: The PD of targeted drugs in children will differ from adults.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
排除标准
- •Failure to obtain consent/assent (as indicated)
- •Known pregnancy as determined via interview or testing if available.
结局指标
主要结局
Composite of pharmacokinetic outcomes for understudied drugs in children
时间窗: Data will be collected throughout the hospital or outpatient stay up to 90 days
As appropriate for each study drug, the following additional PK parameters will be estimated: * maximum concentration (Cmax) * time to achieve maximum concentration (Tmax) * absorption rate constant (ka) * elimination rate constant (kel) * half-life (t1/2) * area under the curve (AUC) Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples.
次要结局
- Composite pharmacodynamic outcomes of understudied drugs in children(Data will be collected throughout the hospital or outpatient stay up to 90 days)
- Biomarkers associated with understudied drugs in children(Data will be collected throughout the hospital or outpatient stay up to 90 days)
研究者
Daniel Benjamin
Professor of Pediatrics
Duke University