Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Maximum Age: 20
Healthy Volunteers: t
View:
• 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
Locations
United States
Arkansas
Arkansas Children's Hospital Research Institute
COMPLETED
Little Rock
Arizona
Phoenix Children's Hospital
COMPLETED
Phoenix
California
University of California, Los Angeles Medical Center
COMPLETED
Los Angeles
Lucile Packard Children's Hospital
RECRUITING
Palo Alto
Colorado
Colorado University Denver
COMPLETED
Aurora
The Children's Hospital Colorado
COMPLETED
Aurora
Delaware
Alfred I. DuPont Hospital for Children
COMPLETED
Wilmington
Florida
University of Florida Jacksonville Shands Medical Center
COMPLETED
Jacksonville
Hawaii
Kapiolani Womens and Childrens Medical Center
COMPLETED
Honolulu
Iowa
University of Iowa Stead Family Children's Hospital
COMPLETED
Iowa City
Illinois
Ann and Robert H. Lurie Childrens Hospital of Chicago
COMPLETED
Chicago
Ann and Robert H. Lurie Childrens Hospital of Chicago
COMPLETED
Chicago
Indiana
Riley Hospital for Children at Indiana University
COMPLETED
Indianapolis
Kansas
University of Kansas Medical Center-JG Kidney Institute
COMPLETED
Kansas City
Kentucky
University of Louisville Norton Childrens Hospital
COMPLETED
Louisville
Louisiana
Ochsner Baptist Clinical Trials Unit
COMPLETED
New Orleans
Tulane University Health Science Center
COMPLETED
New Orleans
Massachusetts
Boston Children's Hospital
COMPLETED
Boston
Massachusetts General Hospital
COMPLETED
Lexington
Maryland
University of Maryland Medical Center
COMPLETED
Baltimore
Minnesota
University of Minnesota
COMPLETED
Minneapolis
Missouri
Children's Mercy Hospital
COMPLETED
Kansas City
Mississippi
University of Mississippi Medical Center
COMPLETED
Jackson
Mississippi Center for Advanced Medicine
COMPLETED
Madison
North Carolina
University of North Carolina at Chapel Hill
COMPLETED
Chapel Hill
Duke University Health System
RECRUITING
Durham
Nebraska
University of Nebraska Medical Center
COMPLETED
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
COMPLETED
Lebanon
New Mexico
University of New Mexico Health Science Center
COMPLETED
Albuquerque
Ohio
Cincinnati Childrens Hospital Medical Center
COMPLETED
Cincinnati
Cincinnati Childrens Hospital Medical Center
RECRUITING
Cincinnati
Oklahoma
Board of Regents of the University of Oklahoma
COMPLETED
Oklahoma City
Oregon
Oregon Health and Science University
COMPLETED
Portland
Pennsylvania
Pennsylvania State University--Hershey Children's Hospital
COMPLETED
Hershey
Rhode Island
Rhode Island Hospital
COMPLETED
Providence
South Carolina
Medical University of South Carolina Children's Hospital
COMPLETED
Charleston
University of South Carolina
COMPLETED
Columbia
South Dakota
Avera McKennan Hospital & University Medical Center
COMPLETED
Sioux Falls
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
COMPLETED
Nashville
Texas
Dell Children's Medical Center of Central Texas
RECRUITING
Austin
University of Texas-Southwestern Medical Center Dallas
COMPLETED
Dallas
Baylor College of Medicine
COMPLETED
Houston
The Womens Hospital of Texas
COMPLETED
Houston
University of Texas--Memorial Hermann Texas Medical Center
COMPLETED
Houston
Utah
University of Utah
COMPLETED
Salt Lake City
Washington
Seattle Children's Hospital
COMPLETED
Seattle
Wisconsin
University of Wisconsin
COMPLETED
Madison
University Wisconsin Madison
COMPLETED
Madison
Medical College of Wisconsin
COMPLETED
Milwaukee
West Virginia
West Virginia University Hospital
COMPLETED
Morgantown
Other Locations
Canada
CHU Sainte-Justine
RECRUITING
Montreal
The Hospital for Sick Children
COMPLETED
Toronto
Contact Information
Primary
Chi Hornik
chi.hornik@duke.edu
(919) 260-7626
Backup
Melissa James, MPH, RD
melissa.james@duke.edu
(704) 502-6491
Time Frame
Start Date: 2020-03-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 5000
Treatments
Children and young adults who are prescribed drugs of interest
Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.
Authors
Chi Hornik
Related Therapeutic Areas
Sponsors
Collaborators: The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Duke University