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POPS-PTN #2

  • Status
    Accepting Candidates
  • Age
    0 Years - 20 Years
  • Sexes
    All
  • Healthy Volunteers
    Accepts Healthy Volunteers
I'm interested
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Objective

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

Full study title Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POPS)
Protocol number OCR42770
ClinicalTrials.gov ID NCT04278404

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)

  1. Has had intermittent dialysis within previous 24 hours

  2. Has had a kidney transplant within previous 30 days

  3. Has had a liver transplant within previous 1 year

  4. Has had a stem cell transplant within previous 1 year

  5. Has had therapeutic hypothermia within previous 24 hours

  6. Has had plasmapheresis within the previous 24 hours

  7. Has a Ventricular Assist Device

  8. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Lead researcher

  • Mobeen H Rathore, MD, CPE, FACPE, FIDSA, FAAP
    Pediatric Infectious Disease Specialist
    Languages: Urdu, Punjabi

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.