Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
- Conditions
- Pulmonary Arterial HypertensionUrinary Tract Infections in ChildrenHemophiliaMenorrhagiaAttention Deficit Hyperactivity DisorderMultisystem Inflammatory Syndrome in Children (MIS-C)Coronavirus Infection (COVID-19)PainHyperphosphatemiaEdema
- Registration Number
- NCT04278404
- Lead Sponsor
- Duke University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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
-
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
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Has a Ventricular Assist Device
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Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Elimination rate constant (ke) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. Half-life (t1/2) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. Time to achieve maximum concentration (Tmax) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. Maximum concentration (Cmax) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. AUC (area under the curve) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days. Absorption rate constant (ka) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
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
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
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke University Health System
🇺🇸Durham, North Carolina, United States
Board of Regents of the University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Pennsylvania State University--Hershey Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Medical University of South Carolina Children's Hospital
🇺🇸Charleston, South Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
CHU Sainte-Justine
🇨🇦Montréal, Quebec, Canada
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, 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
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