Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 6, 2023 · Source: ClinicalTrials.gov
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Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Daniel Benjamin
- Interventions being studied
- Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1\) Children (\< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
- 1\) Failure to obtain consent/assent (as indicated)
- 2\) Known pregnancy as determined via interview or testing if available.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Alaska Native Medical CenterAnchorage, Alaska
- Arkansas Children's HospitalLittle Rock, Arkansas
- University of California at San Diego Medical CenterLa Jolla, California
- Axis Clinical TrialsLos Angeles, California
- University of California, Los Angeles Medical CenterLos Angeles, California
- The Children's Hospital ColoradoAurora, Colorado
- Yale New Haven Children's HospitalNew Haven, Connecticut
- Alfred I. DuPont Hospital for ChildrenWilmington, Delaware
- Children's National Medical CenterWashington D.C., District of Columbia
- University of Florida Jacksonville Shands Medical CenterJacksonville, Florida
- Kapiolani Womens and Childrens Medical CenterHonolulu, Hawaii
- Lurie Children's Hospital of ChicagoChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 6, 2023. Always confirm current availability with the study team.