Pharmacokinetics of Off Label Pediatric Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Area under the curve (AUC)
研究概览
简要总结
The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.
详细描述
There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children less than 8 years of age
- •Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care
排除标准
- •Lack of consent
结局指标
主要结局
Area under the curve (AUC)
时间窗: approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.
actual body exposure to drug after a dose of the drug is administered. this is dependent on on the rate of drug elimination divided by plasma concentration of the drug.
Volume of distribution at steady-state
时间窗: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.
Terminal elimination rate constant (Ke) and Half-Life
时间窗: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Period of time that it takes for the concentration of the drug in the body to be reduced by on-half.
Plasma Clearance
时间窗: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
the rate at which the drug is eliminated from the body divided by the plasma concentration.
次要结局
未报告次要终点