Adrenal Insufficiency, Arrythmia, Asthma in Children, Attention Deficit Hyperactivity Disorder, Bronchopulmonary Dysplasia, Coagulation Disorder, Coronavirus Infection (COVID-19), Down Syndrome, Edema, Fibrinolysis; Hemorrhage, Heart Failure, Hemophilia, Hyperphosphatemia, Hypertension, Hypokalemia, Insomnia, Kawasaki Disease, Menorrhagia, Multisystem Inflammatory Syndrome in Children (MIS-C), Pain, Pneumonia, Primary Hyperaldosteronism, Pulmonary Arterial Hypertension, Skin Infection, Urinary Tract Infections in Children
Conditions
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.
Interventions
DRUGThe 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.
Sponsors
Duke University
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 20 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
| 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. |
| 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. |
Countries
Canada, United States
Contacts
CONTACTChi Hornik
CONTACTMelissa James, MPH, RD
PRINCIPAL_INVESTIGATORChi Hornik
Duke Clinical Research Institute
Outcome results
None listed