Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (NCT04278404) — Canada Trial Details

Condition(s) studied

Coronavirus Infection (COVID-19)Pulmonary Arterial HypertensionUrinary Tract Infections in ChildrenHypertensionPainHyperphosphatemiaPrimary HyperaldosteronismEdemaHypokalemiaHeart FailureHemophiliaMenorrhagiaInsomniaPneumoniaSkin InfectionArrythmiaAsthma in ChildrenBronchopulmonary DysplasiaAdrenal InsufficiencyFibrinolysis; HemorrhageAttention Deficit Hyperactivity DisorderMultisystem Inflammatory Syndrome in Children (MIS-C)Kawasaki DiseaseCoagulation DisorderDown Syndrome

Investigational drug(s) / intervention(s)

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 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.

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.

Eligibility

Sex

ALL

Min age

0 Years

Max age

20 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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.
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.
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.
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.
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.
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.
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.

Trial sites (52)

Facility	City	Region	Status
Phoenix Children's Hospital	Phoenix	Arizona	Completed
Arkansas Children's Hospital Research Institute	Little Rock	Arkansas	Completed
University of California, Los Angeles Medical Center	Los Angeles	California	Completed
Lucile Packard Children's Hospital	Palo Alto	California	Recruiting
Colorado University Denver	Aurora	Colorado	Completed
The Children's Hospital Colorado	Aurora	Colorado	Completed
Alfred I. DuPont Hospital for Children	Wilmington	Delaware	Completed
University of Florida Jacksonville Shands Medical Center	Jacksonville	Florida	Completed
Kapiolani Womens and Childrens Medical Center	Honolulu	Hawaii	Completed
Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois	Completed
Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois	Completed
Riley Hospital for Children at Indiana University	Indianapolis	Indiana	Completed
University of Iowa Stead Family Children's Hospital	Iowa City	Iowa	Completed
University of Kansas Medical Center-JG Kidney Institute	Kansas City	Kansas	Completed
University of Louisville Norton Childrens Hospital	Louisville	Kentucky	Completed
Tulane University Health Science Center	New Orleans	Louisiana	Completed
Ochsner Baptist Clinical Trials Unit	New Orleans	Louisiana	Completed
University of Maryland Medical Center	Baltimore	Maryland	Completed
Boston Children's Hospital	Boston	Massachusetts	Completed
Massachusetts General Hospital	Lexington	Massachusetts	Completed
University of Minnesota	Minneapolis	Minnesota	Completed
University of Mississippi Medical Center	Jackson	Mississippi	Completed
Mississippi Center for Advanced Medicine	Madison	Mississippi	Completed
Children's Mercy Hospital	Kansas City	Missouri	Completed
University of Nebraska Medical Center	Omaha	Nebraska	Completed
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	Completed
University of New Mexico Health Science Center	Albuquerque	New Mexico	Completed
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Completed
Duke University Health System	Durham	North Carolina	Recruiting
Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio	Completed
Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio	Recruiting
Board of Regents of the University of Oklahoma	Oklahoma City	Oklahoma	Completed
Oregon Health and Science University	Portland	Oregon	Completed
Pennsylvania State University--Hershey Children's Hospital	Hershey	Pennsylvania	Completed
Rhode Island Hospital	Providence	Rhode Island	Completed
Medical University of South Carolina Children's Hospital	Charleston	South Carolina	Completed
University of South Carolina	Columbia	South Carolina	Completed
Avera McKennan Hospital & University Medical Center	Sioux Falls	South Dakota	Completed
Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	Completed
Dell Children's Medical Center of Central Texas	Austin	Texas	Recruiting

+ 12 more sites — see the full list on the official registry below.

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