Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)

  • STATUS
    Recruiting
  • End date
    Apr 24, 2024
  • participants needed
    5000
  • sponsor
    Duke University
Updated on 4 March 2022
SARS
Accepts healthy volunteers

Summary

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.

Details
Condition 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
Treatment 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:
Clinical Study IdentifierNCT04278404
SponsorDuke University
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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