Status
Recruiting
Phase
Not applicable
Enrollment
5,000
Locations
51
Results
Not posted
Publications
11
Study 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.
Interventions
DRUG
The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.
Timeline
First posted
Feb 20, 2020
Study start
Mar 5, 2020
Primary completion
Mar 2027
Study completion
Jul 2027
Results posted
Not reported
Registry updated
Jul 15, 2026
Outcomes
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
Time frame · 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
Time frame · 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.
Elimination rate constant (ke) as measured by PK sampling
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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.
Not reported in the indexed record.
Eligibility
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, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria) 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
Study locations
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
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