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.
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:
The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.
Other Name: Array
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,
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
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
University of California
Los Angeles, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
Colorado University Denver
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
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
Kansas City, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
University of Louisville Norton Childrens Hospital
Louisville, Kentucky, United States
Tulane Pediatrics
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
Childrens 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
Kravis Children's Hospital at Mt. Sinai
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 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, Texas, United States
University of Texas--Memorial Hermann Texas Medical Center
Houston, Texas, 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, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
CHU Sainte-Justine
Montréal, Quebec, Canada
Chi Hornik
(919) 260-7626
chi.hornik@duke.edu
Jerry Kirchner
(919) 812-1798
jerry.kirchner@duke.edu
Chi Hornik, Principal Investigator
Duke Clinical Research Institute