Health TrialsbyHealthPanel

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

ConditionsCoronavirus 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
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-20
SponsorDuke University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Participant is < 21 years of age

(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

Disqualifiers

Participant has a known pregnancy

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

Trial population

Children under 21 years of age.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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:

    Drug

    The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Children and young adults who are prescribed drugs of interest1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

The Emmes Company, LLC

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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