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

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

Recruiting
20 years and younger
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Participant is < 21 years of age
  2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
  3. (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:

  1. 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)

  2. Has had intermittent dialysis within previous 24 hours
  3. Has had a kidney transplant within previous 30 days
  4. Has had a liver transplant within previous 1 year
  5. Has had a stem cell transplant within previous 1 year
  6. Has had therapeutic hypothermia within previous 24 hours
  7. Has had plasmapheresis within the previous 24 hours
  8. Has a Ventricular Assist Device
  9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Study details
    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

NCT04278404

Duke University

15 April 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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