Studies how drugs given to children with several conditions act in the body
Measures how standard drugs act in children and young adults receiving them.
Plain-language title generated from the registry record
Registry title: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Key facts
- Where
- Albuquerque, Aurora, Austin, Baltimore, Boston, Chapel Hill, Charleston, Chicago, Cincinnati, Columbia, Dallas, Durham, Hershey, Honolulu, Houston, Indianapolis, Iowa City, Jackson, Jacksonville, Kansas City, Lebanon, Lexington, Little Rock, Los Angeles, Louisville, Madison, Milwaukee, Minneapolis, Morgantown, Nashville, New Orleans, Oklahoma City, Omaha, Palo Alto, Phoenix, Portland, Providence, Salt Lake City, Seattle, Sioux Falls, and Wilmington, United StatesSee the 48 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 20 years old?
Source: NCT04278404, who can take part
Where in United States
- University of New Mexico Health Science CenterAlbuquerque, United StatesNo longer taking part
- Colorado University DenverAurora, United StatesNo longer taking part
- The Children's Hospital ColoradoAurora, United StatesNo longer taking part
- Dell Children's Medical Center of Central TexasAustin, United StatesTaking people
- University of Maryland Medical CenterBaltimore, United StatesNo longer taking part
- Boston Children's HospitalBoston, United StatesNo longer taking part
- University of North Carolina at Chapel HillChapel Hill, United StatesNo longer taking part
- Medical University of South Carolina Children's HospitalCharleston, United StatesNo longer taking part
- Ann and Robert H Lurie Childrens Hospital of ChicagoChicago, United StatesNo longer taking part
- Cincinnati Childrens Hospital Medical CenterCincinnati, United StatesNo longer taking part
- University of South CarolinaColumbia, United StatesNo longer taking part
- University of Texas Southwestern Medical Center - DallasDallas, United StatesNo longer taking part
- Duke University Health SystemDurham, United StatesTaking people
- Pennsylvania State University--Hershey Children's HospitalHershey, United StatesNo longer taking part
- Kapiolani Womens and Childrens Medical CenterHonolulu, United StatesNo longer taking part
- Baylor College of MedicineHouston, United StatesNo longer taking part
- The Womens Hospital of TexasHouston, United StatesNo longer taking part
- University of Texas--Memorial Hermann Texas Medical CenterHouston, United StatesNo longer taking part
- Riley Hospital for Children at Indiana UniversityIndianapolis, United StatesNo longer taking part
- University of Iowa Stead Family Children's HospitalIowa City, United StatesNo longer taking part
- University of Mississippi Medical CenterJackson, United StatesNo longer taking part
- University of Florida Jacksonville Shands Medical CenterJacksonville, United StatesNo longer taking part
- Children's Mercy HospitalKansas City, United StatesNo longer taking part
- University of Kansas Medical Center-JG Kidney InstituteKansas City, United StatesNo longer taking part
- Dartmouth Hitchcock Medical CenterLebanon, United StatesNo longer taking part
- Massachusetts General HospitalLexington, United StatesNo longer taking part
- Arkansas Children's Hospital Research InstituteLittle Rock, United StatesNo longer taking part
- University of California Los Angeles Medical CenterLos Angeles, United StatesNo longer taking part
- University of Louisville Norton Childrens HospitalLouisville, United StatesNo longer taking part
- Mississippi Center for Advanced MedicineMadison, United StatesNo longer taking part
- University of WisconsinMadison, United StatesNo longer taking part
- University Wisconsin MadisonMadison, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- University of MinnesotaMinneapolis, United StatesNo longer taking part
- West Virginia University HospitalMorgantown, United StatesNo longer taking part
- Monroe Carell Jr. Children's Hospital at VanderbiltNashville, United StatesNo longer taking part
- Ochsner Baptist Clinical Trials UnitNew Orleans, United StatesNo longer taking part
- Tulane University Health Science CenterNew Orleans, United StatesNo longer taking part
- Board of Regents of the University of OklahomaOklahoma City, United StatesNo longer taking part
- University of Nebraska Medical CenterOmaha, United StatesNo longer taking part
- Lucile Packard Children's HospitalPalo Alto, United StatesTaking people
- Phoenix Children s HospitalPhoenix, United StatesNo longer taking part
- Oregon Health and Science UniversityPortland, United StatesNo longer taking part
- Rhode Island HospitalProvidence, United StatesNo longer taking part
- University of UtahSalt Lake City, United StatesNo longer taking part
- Seattle Children's HospitalSeattle, United StatesNo longer taking part
- Avera McKennan Hospital & University Medical CenterSioux Falls, United StatesNo longer taking part
- Alfred I duPont Hospital for ChildrenWilmington, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT04278404
- Record updated
- 21 August 2026
- Original description
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.Read full original descriptionShow less
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Inclusion: Participant is < 21 years of age; Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:; (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment.
Exclusion: Participant has a known pregnancy; Below exclusion criteria apply only to:; Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria); Has had intermittent dialysis within previous 24 hours; Has had a kidney transplant within previous 30 days; Has had a liver transplant within previous 1 year; Has had a stem cell transplant within previous 1 year; Has had therapeutic hypothermia within previous 24 hours; Has had plasmapheresis within the previous 24 hours; Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study; Has a Ventricular Assist Device.