Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Duke University5,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Coronavirus Infection (COVID-19)Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema

Eligibility

Sex: ALLMin age: 0 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (51)

Phoenix Children's Hospital

Phoenix, Arizona, United States

ACTIVE_NOT_RECRUITING

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

RECRUITING

University of California, Los Angeles Medical Center

Los Angeles, California, United States

RECRUITING

Lucile Packard Children's Hospital

Palo Alto, California, United States

Outcomes

Primary 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

Elimination rate constant (ke) as measured by PK sampling

Half-life (t1/2) as measured by PK sampling

Absorption rate constant (ka) as measured by PK sampling

AUC (area under the curve) as measured by PK sampling

Maximum concentration (Cmax) as measured by PK sampling

Time to achieve maximum concentration (Tmax) as measured by PK sampling