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

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

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.

Sponsors & Collaborators

• The Emmes Company, LLC

  collaborator INDUSTRY

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

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Chi Hornik · Duke Clinical Research Institute

Eligibility

Min Age

0 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-05

Primary Completion

2027-03-31

Completion

2027-07-31

Countries

• United States
• Canada

Study Locations