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NCT04278404Recruiting

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

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
18 Feb 2020
Start date
5 Mar 2020
Primary completion date
Nov 2026
Lead sponsor
Duke University
NCT number
NCT04278404

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 5 Mar 2020 to the primary completion date, Nov 2026
  • 50 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Other

  • Has a Ventricular Assist Device

Who the study is looking for

  • 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

Age in the registry: 0 years to 20 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Sainte-Justine
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
The Hospital for Sick Children
Coordinator of this site? Confirm its status
TorontoCanadaCompleted
University of New Mexico Health Science Center
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesCompleted
The Children's Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesCompleted
Colorado University Denver
Coordinator of this site? Confirm its status
AuroraUnited StatesCompleted
Dell Children's Medical Center of Central Texas
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
University of Maryland Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesCompleted
Boston Children's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesCompleted
University of North Carolina at Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesCompleted
Medical University of South Carolina Children's Hospital
Coordinator of this site? Confirm its status
CharlestonUnited StatesCompleted
Ann and Robert H Lurie Childrens Hospital of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesCompleted
Cincinnati Childrens Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesCompleted
University of South Carolina
Coordinator of this site? Confirm its status
ColumbiaUnited StatesCompleted
University of Texas Southwestern Medical Center - Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesCompleted
Duke University Health System
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Pennsylvania State University--Hershey Children's Hospital
Coordinator of this site? Confirm its status
HersheyUnited StatesCompleted
Kapiolani Womens and Childrens Medical Center
Coordinator of this site? Confirm its status
HonoluluUnited StatesCompleted
University of Texas--Memorial Hermann Texas Medical Center
Coordinator of this site? Confirm its status
HoustonUnited StatesCompleted
Baylor College of Medicine
Coordinator of this site? Confirm its status
HoustonUnited StatesCompleted
The Womens Hospital of Texas
Coordinator of this site? Confirm its status
HoustonUnited StatesCompleted
Riley Hospital for Children at Indiana University
Coordinator of this site? Confirm its status
IndianapolisUnited StatesCompleted
University of Iowa Stead Family Children's Hospital
Coordinator of this site? Confirm its status
Iowa CityUnited StatesCompleted
University of Mississippi Medical Center
Coordinator of this site? Confirm its status
JacksonUnited StatesCompleted
University of Florida Jacksonville Shands Medical Center
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesCompleted
University of Kansas Medical Center-JG Kidney Institute
Coordinator of this site? Confirm its status
Kansas CityUnited StatesCompleted
Children's Mercy Hospital
Coordinator of this site? Confirm its status
Kansas CityUnited StatesCompleted
Dartmouth Hitchcock Medical Center
Coordinator of this site? Confirm its status
LebanonUnited StatesCompleted
Massachusetts General Hospital
Coordinator of this site? Confirm its status
LexingtonUnited StatesCompleted
Arkansas Children's Hospital Research Institute
Coordinator of this site? Confirm its status
Little RockUnited StatesCompleted
University of California Los Angeles Medical Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesCompleted
University of Louisville Norton Childrens Hospital
Coordinator of this site? Confirm its status
LouisvilleUnited StatesCompleted
University Wisconsin Madison
Coordinator of this site? Confirm its status
MadisonUnited StatesCompleted
University of Wisconsin
Coordinator of this site? Confirm its status
MadisonUnited StatesCompleted
Mississippi Center for Advanced Medicine
Coordinator of this site? Confirm its status
MadisonUnited StatesCompleted
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesCompleted
University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesCompleted
West Virginia University Hospital
Coordinator of this site? Confirm its status
MorgantownUnited StatesCompleted
Monroe Carell Jr. Children's Hospital at Vanderbilt
Coordinator of this site? Confirm its status
NashvilleUnited StatesCompleted
Tulane University Health Science Center
Coordinator of this site? Confirm its status
New OrleansUnited StatesCompleted
Ochsner Baptist Clinical Trials Unit
Coordinator of this site? Confirm its status
New OrleansUnited StatesCompleted
Board of Regents of the University of Oklahoma
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesCompleted
University of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesCompleted
Lucile Packard Children's Hospital
Coordinator of this site? Confirm its status
Palo AltoUnited StatesRecruiting
Phoenix Children s Hospital
Coordinator of this site? Confirm its status
PhoenixUnited StatesCompleted
Oregon Health and Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesCompleted
Rhode Island Hospital
Coordinator of this site? Confirm its status
ProvidenceUnited StatesCompleted
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesCompleted
Seattle Children's Hospital
Coordinator of this site? Confirm its status
SeattleUnited StatesCompleted
Avera McKennan Hospital & University Medical Center
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesCompleted
Alfred I duPont Hospital for Children
Coordinator of this site? Confirm its status
WilmingtonUnited StatesCompleted

This page is information, not medical advice. Discuss any trial with your doctor.