Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Sponsored by Duke University
About this study
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.
Where this study is enrolling (3)
- I'm interested
Lucile Packard Children's Hospital
Palo Alto, California
- I'm interested
Duke University Health System
Durham, North Carolina
- I'm interested
Dell Children's Medical Center of Central Texas
Austin, Texas
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.