Clinical Research Details

Clinical Research

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

Study 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.

Inclusion/Exclusion Criteria

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
1. 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:
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

Open Enrollment

Contact Name: Saniyyah Mahmoudi
Contact Phone: (904) 224-5331
Contact Email: saniyyah.mahmoudi@jax.ufl.edu

Investigators