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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

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 (a) Participant is < 21 years of age and is receiving understudied drugs of interest (DOIs) per standard of care (SOC) as prescribed by their treating provider 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

2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA

Exclusion Criteria:

  1. Participant has a known pregnancy

For 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)

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
    Pulmonary Disease
    Adrenal Insufficiency
    Arrhythmia
    Arrhythmia
    Edema
    Down Syndrome
    Coagulopathy
    Oppositional Defiant Disorder
    Vascular Diseases
    Vascular Diseases
    Attention deficit hyperactivity disorder
    Hyperphosphatemia
    Heart failure
    Heart failure
    Heart disease
    Heart disease
    Insomnia
    Insomnia
    Upper respiratory infection
    Hypokalemia
    Kawasaki Disease
    Kawasaki Disease
    Bronchopulmonary Dysplasia
    Hypertension
    Hemophilia A
    Pneumonia
    Pneumonia
    Hyperaldosteronism
    skin infection
    Menorrhagia
    Hypomenorrhea
    Pain
    Pain
    Acute Pain Service
    Asthma in Children
    Pulmonary Arterial Hypertension
    Urinary Tract Infections in Children
    Fibrinolysis; Hemorrhage
    Multisystem Inflammatory Syndrome in Children (MIS-C)

NCT04278404

Duke University

16 February 2024

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