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
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Completed |
| University of New Mexico Health Science Center Coordinator of this site? Confirm its status | Albuquerque | United States | Completed |
| The Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Completed |
| Colorado University Denver Coordinator of this site? Confirm its status | Aurora | United States | Completed |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Completed |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Completed |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Completed |
| Medical University of South Carolina Children's Hospital Coordinator of this site? Confirm its status | Charleston | United States | Completed |
| Ann and Robert H Lurie Childrens Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Completed |
| Cincinnati Childrens Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Completed |
| University of South Carolina Coordinator of this site? Confirm its status | Columbia | United States | Completed |
| University of Texas Southwestern Medical Center - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Completed |
| Duke University Health System Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Pennsylvania State University--Hershey Children's Hospital Coordinator of this site? Confirm its status | Hershey | United States | Completed |
| Kapiolani Womens and Childrens Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Completed |
| University of Texas--Memorial Hermann Texas Medical Center Coordinator of this site? Confirm its status | Houston | United States | Completed |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Completed |
| The Womens Hospital of Texas Coordinator of this site? Confirm its status | Houston | United States | Completed |
| Riley Hospital for Children at Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Completed |
| University of Iowa Stead Family Children's Hospital Coordinator of this site? Confirm its status | Iowa City | United States | Completed |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Completed |
| University of Florida Jacksonville Shands Medical Center Coordinator of this site? Confirm its status | Jacksonville | United States | Completed |
| University of Kansas Medical Center-JG Kidney Institute Coordinator of this site? Confirm its status | Kansas City | United States | Completed |
| Children's Mercy Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Completed |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Completed |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Lexington | United States | Completed |
| Arkansas Children's Hospital Research Institute Coordinator of this site? Confirm its status | Little Rock | United States | Completed |
| University of California Los Angeles Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Completed |
| University of Louisville Norton Childrens Hospital Coordinator of this site? Confirm its status | Louisville | United States | Completed |
| University Wisconsin Madison Coordinator of this site? Confirm its status | Madison | United States | Completed |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Completed |
| Mississippi Center for Advanced Medicine Coordinator of this site? Confirm its status | Madison | United States | Completed |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Completed |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Completed |
| West Virginia University Hospital Coordinator of this site? Confirm its status | Morgantown | United States | Completed |
| Monroe Carell Jr. Children's Hospital at Vanderbilt Coordinator of this site? Confirm its status | Nashville | United States | Completed |
| Tulane University Health Science Center Coordinator of this site? Confirm its status | New Orleans | United States | Completed |
| Ochsner Baptist Clinical Trials Unit Coordinator of this site? Confirm its status | New Orleans | United States | Completed |
| Board of Regents of the University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Completed |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Completed |
| Lucile Packard Children's Hospital Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Completed |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Completed |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Completed |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Completed |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Completed |
| Avera McKennan Hospital & University Medical Center Coordinator of this site? Confirm its status | Sioux Falls | United States | Completed |
| Alfred I duPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.