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

Duke University · with The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT04278404

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 0 mo–20 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
5000
US sites recruiting
4
Study start
March 5, 2020
Record last updated
August 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: 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:

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Recruiting US locations

  • Lucile Packard Children's Hospital

    Palo Alto, CA 94304

    Site contact: Yasaman Nourkhala · 650-724-4548 · yasinour@stanford.edu

  • Duke University Health System

    Durham, NC 27710

    Site contact: Melissa Harward · 919-668-3910 · melissa.harward@dm.duke.edu

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, OH 45229

    Site contact: Kelli Krallman · 513-636-4837 · kelli.krallman@cchmc.org

  • Dell Children's Medical Center of Central Texas

    Austin, TX 78723

    Site contact: Michael Box · 512-820-2136 · michael.box@ascension-external.org

Study contacts (from the official record)

  • Chi Hornik · (919) 260-7626 · chi.hornik@duke.edu
  • Melissa James, MPH, RD · (704) 502-6491 · melissa.james@duke.edu
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