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

ConditionsCoronavirus Infection (COVID-19)Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Menorrhagia Insomnia Pneumonia Skin Infection Arrythmia Asthma in Children Bronchopulmonary Dysplasia Adrenal Insufficiency Fibrinolysis; Hemorrhage Attention Deficit Hyperactivity Disorder Multisystem Inflammatory Syndrome in Children (MIS-C)Kawasaki Disease Coagulation Disorder Down 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

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 design

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:

Treatment groups

5,000 Participants

are divided into 1 treatment group

Locations

Canada

The Hospital for Sick Children TorontoOntario, Canada

CHU Sainte-JustineH3T 1C5, MontrealQuebec, Canada

United States

Arizona

Phoenix Children's Hospital85016, Phoenix United States

Arkansas

Arkansas Children's Hospital Research Institute72202, Little Rock United States

Sponsors and collaborators

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