Understanding Drug Effects in Children (POPS Study)
This observational study, called POPS, aims to understand how certain drugs affect children and young adults (ages 0-20). Researchers are interested in drugs that are already prescribed by doctors for conditions like Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections, Hypertension, and Pain. The goal is to find the safest and most effective doses for children. You can join if you are under 21 and are already taking one of the study drugs, or if you are SARS-COV-2 positive. Researchers will collect bodily fluid samples (like blood) to measure how the drugs move through and are cleared from the body. The study plans to enroll 5000 participants.
- Study design
- This is an observational study, meaning researchers will watch and collect information without giving new treatments. It plans to include 5000 participants.
- What's involved
- If you participate, bodily fluid samples (like blood) will be collected. Data will be collected for up to 90 days, or up to 210 days for participants with Down Syndrome.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 90 days from consent, or up to 210 days for participants with Down Syndrome.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04278404
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Recruiting
Not specifiedAges 0–20ObservationalDuke UniversityInvestigator-initiated
~5,000 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
At a glance
Recruiting sites
5 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
Measured over Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
+7 more outcomes measured
Conditions
Where it's being run
52 sites across 37 statesTexas5
Wisconsin3
California2
Colorado2
Illinois2
Louisiana2
Massachusetts2
Mississippi2
Study leadership
- Chi Hornik · PRINCIPAL_INVESTIGATOR · Duke Clinical Research Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Clearance (CL) or apparent oral clearance (CL/F) as measured by PK samplingData will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
- Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK samplingData will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
- Elimination rate constant (ke) as measured by PK samplingData will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
- Half-life (t1/2) as measured by PK samplingData will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
- Absorption rate constant (ka) as measured by PK samplingData will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
- AUC (area under the curve) as measured by PK samplingData will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
- Maximum concentration (Cmax) as measured by PK samplingData will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
- Time to achieve maximum concentration (Tmax) as measured by PK samplingData will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.