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

  • STATUS
    Recruiting
  • participants needed
    5000
  • sponsor
    Duke University
Updated on 19 February 2024
SARS
acute respiratory syndrome (sars)

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, 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)
Age 20years or below
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 on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

(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
\. 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
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)
\. 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
Clear my responses

How to participate?

Step 1 Connect with a study center
Entire World
Results (35 sites found)
  • 1

    Arkansas Children's Hospital Research Institute

    Little Rock AR United States

  • 2

    Colorado University Denver

    Aurora CO United States

  • 3

    Alfred I. DuPont Hospital for Children

    Wilmington DE United States

  • 4

    University of Florida Jacksonville Shands Medical Center

    Jacksonville FL United States

  • 5

    Kapiolani Womens and Childrens Medical Center

    Honolulu HI United States

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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