Pediatric ALL
Conditions
Keywords
pharmacokinetics
Brief summary
This is a prospective study of children \<21 years of age with the goal of characterizing the PK of drugs administered per standard of care as prescribed by the treating caregiver.
Interventions
DRUGStandard of care drug
This study is collecting PK data on children prescribed the following drugs of interest per standard of care: dexmedetomidine, bosentan, furosemide, chlorothiazide, ethacrynic acid, bumetanide, hydromorphone, tacrolimus, ampicillin, gentamicin, caffeine, fentanyl, midazolam, foscarnet, hydroxychloroquine, and moxifloxacin.
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Children (\< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
Exclusion criteria
* Failure to obtain consent/assent (as indicated)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) | Data will be collected throughout the hospital or outpatient stay up to 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | Data will be collected throughout the hospital or outpatient stay up to 90 days |
| Time to achieve maximum concentration (Tmax) | Data will be collected throughout the hospital or outpatient stay up to 90 days |
| Absorption rate constant (ka) | Data will be collected throughout the hospital or outpatient stay up to 90 days |
| Elimination rate constant (kel) | Data will be collected throughout the hospital or outpatient stay up to 90 days |
| Half-life (t1/2) | Data will be collected throughout the hospital or outpatient stay up to 90 days |
Countries
United States
Contacts
Primary ContactRachel G Greenberg, MD
Outcome results
None listed