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

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

0 Years - 20 Years

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Mar 5, 2020

Status verified

Mar 2026

Primary completion

Mar 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

5,000 participants (estimated)

Arms

• Arm: Children and young adults who are prescribed drugs of interest
  Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.

Primary Outcome Measure

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. ]

Central Contacts

• Chi Hornik
  (919) 260-7626
  [email protected]
• Melissa James, MPH, RD
  (704) 502-6491
  [email protected]

Locations (49)

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