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Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
NCT04278404 · Duke University
In plain English
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Official title
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Participant is \< 21 years of age
2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
3. (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 Criteria:
1. 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)
2. Has had intermittent dialysis within previous 24 hours
3. Has had a kidney transplant within previous 30 days
4. Has had a liver transplant within previous 1 year
5. Has had a stem cell transplant within previous 1 year
6. Has had therapeutic hypothermia within previous 24 hours
7. Has had plasmapheresis within the previous 24 hours
8. Has a Ventricular Assist Device
9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Study design
Enrollment target: 5000 participants
Age groups: child, adult
Timeline
Starts: 2020-03-05
Estimated completion: 2027-07
Last updated: 2026-04-06
Interventions
Drug: 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:
Primary outcomes
- • Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling (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.)
- • Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling (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.)
- • Elimination rate constant (ke) as measured by PK sampling (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.)
Sponsor
Duke University · other
With: The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contacts & investigators
ContactChi Hornik · contact · chi.hornik@duke.edu · (919) 260-7626
ContactMelissa James, MPH, RD · contact · melissa.james@duke.edu · (704) 502-6491
InvestigatorChi Hornik · principal_investigator, Duke Clinical Research Institute
All locations (51)
Phoenix Children's HospitalCompleted
Phoenix, Arizona, United States
Arkansas Children's Hospital Research InstituteRecruiting
Little Rock, Arkansas, United States
University of California, Los Angeles Medical CenterRecruiting
Los Angeles, California, United States
Lucile Packard Children's HospitalRecruiting
Palo Alto, California, United States
Colorado University DenverRecruiting
Aurora, Colorado, United States
The Children's Hospital ColoradoCompleted
Aurora, Colorado, United States
Alfred I. DuPont Hospital for ChildrenCompleted
Wilmington, Delaware, United States
University of Florida Jacksonville Shands Medical CenterRecruiting
Jacksonville, Florida, United States
Kapiolani Womens and Childrens Medical CenterRecruiting
Honolulu, Hawaii, United States
Ann and Robert H. Lurie Childrens Hospital of ChicagoCompleted
Chicago, Illinois, United States
Ann and Robert H. Lurie Childrens Hospital of ChicagoRecruiting
Chicago, Illinois, United States
Riley Hospital for Children at Indiana UniversityRecruiting
Indianapolis, Indiana, United States
University of Iowa Stead Family Children's HospitalCompleted
Iowa City, Iowa, United States
University of Kansas Medical Center-JG Kidney InstituteCompleted
Kansas City, Kansas, United States
University of Louisville Norton Childrens HospitalRecruiting
Louisville, Kentucky, United States
Tulane University Health Science CenterCompleted
New Orleans, Louisiana, United States
Ochsner Baptist Clinical Trials UnitRecruiting
New Orleans, Louisiana, United States
University of Maryland Medical CenterCompleted
Baltimore, Maryland, United States
Boston Children's HospitalCompleted
Boston, Massachusetts, United States
Massachusetts General HospitalCompleted
Lexington, Massachusetts, United States
University of MinnesotaCompleted
Minneapolis, Minnesota, United States
University of Mississippi Medical CenterRecruiting
Jackson, Mississippi, United States
Mississippi Center for Advanced MedicineCompleted
Madison, Mississippi, United States
Children's Mercy HospitalCompleted
Kansas City, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical CenterCompleted
Lebanon, New Hampshire, United States
University of New Mexico Health Science CenterCompleted
Albuquerque, New Mexico, United States
University of North Carolina at Chapel HillCompleted
Chapel Hill, North Carolina, United States
Duke University Health SystemRecruiting
Durham, North Carolina, United States
Cincinnati Childrens Hospital Medical CenterCompleted
Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
Board of Regents of the University of OklahomaRecruiting
Oklahoma City, Oklahoma, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Pennsylvania State University--Hershey Children's HospitalCompleted
Hershey, Pennsylvania, United States
Rhode Island HospitalCompleted
Providence, Rhode Island, United States
Medical University of South Carolina Children's HospitalRecruiting
Charleston, South Carolina, United States
University of South CarolinaCompleted
Columbia, South Carolina, United States
Avera McKennan Hospital & University Medical CenterCompleted
Sioux Falls, South Dakota, United States
Monroe Carell Jr. Children's Hospital at VanderbiltRecruiting
Nashville, Tennessee, United States
Dell Children's Medical Center of Central TexasRecruiting
Austin, Texas, United States
University of Texas-Southwestern Medical Center DallasActive Not Recruiting
Dallas, Texas, United States
University of Texas--Memorial Hermann Texas Medical CenterCompleted
Houston, Texas, United States
The Womens Hospital of TexasRecruiting
Houston, Texas, United States
University of UtahRecruiting
Salt Lake City, Utah, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
West Virginia University HospitalActive Not Recruiting
Morgantown, West Virginia, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States
University Wisconsin MadisonCompleted
Madison, Wisconsin, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
The Hospital for Sick ChildrenRecruiting
Toronto, Ontario, Canada
CHU Sainte-JustineRecruiting
Montreal, Quebec, Canada