Study of How Understudied Drugs Work and Their Safety in Children and Young Adults Up to Age 20

What this Trial Is About

Researchers are studying how drugs given to children and young adults by their healthcare providers work in their bodies. The goal is to find the safest and most effective doses of these understudied drugs currently used as part of standard care. This observational study focuses on children up to 20 years old, including those who are SARS-CoV-2 positive, across various medical conditions. Participants are observed while receiving their prescribed drugs as part of their routine medical care. The study collects bodily fluid samples, such as whole blood and effluent samples, to measure how the drugs are processed in the body. Data collection lasts up to 90 days from consent, with an extended period of up to 210 days for participants with Down Syndrome at designated sites. During the study, participants will have samples taken to measure drug clearance, volume of distribution, elimination rate, half-life, absorption rate, area under the curve, maximum concentration, and time to maximum concentration. These measurements help researchers understand the pharmacokinetics and safety of the drugs. The study is sponsored by Duke University and participation may last several months depending on individual factors.

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)