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(904) 244-0411

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care / (POPS) (20193297)

  • Status
    Accepting Candidates
  • Age
    0 Years - 20 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

This study is interested in learning more about how drugs, that are given to children by their health care providers, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children.

Details

Protocol number 1283493

Eligibility

Inclusion Criteria

To be eligible for enrollment, a potential participant must meet all the following 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

  4. Participant has a known pregnancy Below exclusion criteria apply only to:  Participants receiving study drug(s) of interest at the time of enrollment, Drug of Interest administration or PK blood sampling:

  5. Has had intermittent dialysis within previous 24 hours

  6. Has had a kidney transplant within previous 30 days

  7. Has had a liver transplant within previous 1 year

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

  9. Has had therapeutic hypothermia within previous 24 hours

  10. Has had plasmapheresis within the previous 24 hours

  11. Has a Ventricular Assist Device

  12. 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, FAAP
    Pediatric Infectious Diseases Physician
    Languages: Urdu, Punjabi

Participate in a study

Here are some general steps to consider when participating in a research study:

  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.