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

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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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    0 to 20

Participation Criteria

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 Location

CHU Sainte-Justine
CHU Sainte-Justine
Montréal, Quebec
Canada

Contact Study Team

Backup Contact

Vincent Lague

[email protected]
514-345-4931
Primary Contact

Clothilde Gravel

[email protected]
514-345-4931
The Hospital for Sick Children
The Hospital for Sick Children
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Maggie Rumantir

[email protected]
416-813-7654
Backup Contact

Justin Williamson

[email protected]
416-813-7654
Study Sponsored By
Duke University
Participants Required
More Information
Study ID: NCT04278404