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

Recruiting now

Conditions studied: 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

In brief

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 facts

Study ID

NCT04278404

Run by

Duke University

People needed

5000

Starts

2020-03-05

Expected to finish

2027-07-01

Last updated by the study team

2026-07-15

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant is < 21 years of age
• Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• (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

You may not qualify if…

• Participant has a known pregnancy
• Below exclusion criteria apply only to:
• Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)
• 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
• Has had a stem cell transplant within previous 1 year
• Has had therapeutic hypothermia within previous 24 hours
• Has had plasmapheresis within the previous 24 hours
• Has a Ventricular Assist Device
• Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Where it is running

• Dell Children's Medical Center of Central Texas — Austin, Texas, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Board of Regents of the University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• University of Wisconsin — Madison, Wisconsin, United States (enrolling)
• Lucile Packard Children's Hospital — Palo Alto, California, United States (enrolling)
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Medical University of South Carolina Children's Hospital — Charleston, South Carolina, United States (enrolling)
• The Womens Hospital of Texas — Houston, Texas, United States (enrolling)
• University of California, Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• University of Louisville Norton Childrens Hospital — Louisville, Kentucky, United States (enrolling)
• University of Florida Jacksonville Shands Medical Center — Jacksonville, Florida, United States (enrolling)
• Ochsner Baptist Clinical Trials Unit — New Orleans, Louisiana, United States (enrolling)
• Kapiolani Womens and Childrens Medical Center — Honolulu, Hawaii, United States (enrolling)
• Duke University Health System — Durham, North Carolina, United States (enrolling)
• Colorado University Denver — Aurora, Colorado, United States (enrolling)
• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Riley Hospital for Children at Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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