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

RecruitingObservational studyHealthy volunteers welcome

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Who can join

Ages 0 to 20 · All sexes · Healthy volunteers welcome

Full eligibility 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

About the 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.

What is being tested

Sponsor: Duke University · Participants: 5,000 · Started: Mar 5, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04278404

Locations in the U.S.

CaliforniaLucile Packard Children's Hospital, Palo Alto
North CarolinaDuke University Health System, Durham
OhioCincinnati Childrens Hospital Medical Center, Cincinnati
TexasDell Children's Medical Center of Central Texas, Austin

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.