Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Recruiting · NCT04278404 · Observational (researchers observe without assigning treatment) · Lead sponsor: Duke University
View the official record on ClinicalTrials.gov →Interventions studied
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:
What this trial is about
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.
Who can take part
Age range
0 Years to 20 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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 a Ventricular Assist Device
- Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Where it is running
52 locations listed across 35 US states.
- Phoenix Children's Hospital - Phoenix, Arizona, United States
- Arkansas Children's Hospital Research Institute - Little Rock, Arkansas, United States
- University of California, Los Angeles Medical Center - Los Angeles, California, United States
- Lucile Packard Children's Hospital - Palo Alto, California, United States
- Colorado University Denver - Aurora, Colorado, United States
- The Children's Hospital Colorado - Aurora, Colorado, United States
- Alfred I. DuPont Hospital for Children - Wilmington, Delaware, United States
- University of Florida Jacksonville Shands Medical Center - Jacksonville, Florida, United States
- Kapiolani Womens and Childrens Medical Center - Honolulu, Hawaii, United States
- Ann and Robert H. Lurie Childrens Hospital of Chicago - Chicago, Illinois, United States
- Ann and Robert H. Lurie Childrens Hospital of Chicago - Chicago, Illinois, United States
- Riley Hospital for Children at Indiana University - Indianapolis, Indiana, United States
- University of Iowa Stead Family Children's Hospital - Iowa City, Iowa, United States
- University of Kansas Medical Center-JG Kidney Institute - Kansas City, Kansas, United States
- University of Louisville Norton Childrens Hospital - Louisville, Kentucky, United States
- Tulane University Health Science Center - New Orleans, Louisiana, United States
- Ochsner Baptist Clinical Trials Unit - New Orleans, Louisiana, United States
- University of Maryland Medical Center - Baltimore, Maryland, United States
- Boston Children's Hospital - Boston, Massachusetts, United States
- Massachusetts General Hospital - Lexington, Massachusetts, United States
- University of Minnesota - Minneapolis, Minnesota, United States
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- Mississippi Center for Advanced Medicine - Madison, Mississippi, United States
- Children's Mercy Hospital - Kansas City, Missouri, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States
- University of New Mexico Health Science Center - Albuquerque, New Mexico, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Duke University Health System - Durham, North Carolina, United States
- Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio, United States
- Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio, United States
- Board of Regents of the University of Oklahoma - Oklahoma City, Oklahoma, United States
- Oregon Health and Science University - Portland, Oregon, United States
- Pennsylvania State University--Hershey Children's Hospital - Hershey, Pennsylvania, United States
- Rhode Island Hospital - Providence, Rhode Island, United States
- Medical University of South Carolina Children's Hospital - Charleston, South Carolina, United States
- University of South Carolina - Columbia, South Carolina, United States
- Avera McKennan Hospital & University Medical Center - Sioux Falls, South Dakota, United States
- Monroe Carell Jr. Children's Hospital at Vanderbilt - Nashville, Tennessee, United States
- Dell Children's Medical Center of Central Texas - Austin, Texas, United States
- University of Texas-Southwestern Medical Center Dallas - Dallas, Texas, United States
- Baylor College of Medicine - Houston, Texas, United States
- University of Texas--Memorial Hermann Texas Medical Center - Houston, Texas, United States
- The Womens Hospital of Texas - Houston, Texas, United States
- University of Utah - Salt Lake City, Utah, United States
- Seattle Children's Hospital - Seattle, Washington, United States
- West Virginia University Hospital - Morgantown, West Virginia, United States
- University of Wisconsin - Madison, Wisconsin, United States
- University Wisconsin Madison - Madison, Wisconsin, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- The Hospital for Sick Children - Toronto, Ontario, Canada
- CHU Sainte-Justine - Montreal, Quebec, Canada