NCT04278404

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

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 0 Years – 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coronavirus 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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2020-03-05
• Primary completion: 2027-03-01
• Completion: 2027-07-01
• First posted: 2020-02-20
• Last updated: 2026-04-06

Locations

51 sites across 2 countries: United States, Canada