Clinical trial
Pharmacokinetics of Drugs Administered to Children Per Standard of Care
Name
Pro00042519
Description
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.
Trial arms
Trial start
2013-08-14
Estimated PCD
2033-08-14
Trial end
2033-08-14
Status
Recruiting
Treatment
Standard 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.
Size
200
Primary endpoint
Area under the curve (AUC)
Data will be collected throughout the hospital or outpatient stay up to 90 days
Eligibility criteria
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)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-12-08
1 organization
1 product
1 indication
Organization
Duke UniversityProduct
Standard of careIndication
Pediatric Acute Lymphoblastic Leukemia