Pharmacokinetics of Drugs Administered to Children Per Standard of Care

Duke University1 site in 1 country200 target enrollmentAugust 14, 2013

ConditionsPediatric ALL

DrugsStandard of care drug

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pediatric ALL
Sponsor: Duke University
Enrollment: 200
Locations: 1
Primary Endpoint: Area under the curve (AUC)
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 14, 2013

End Date

August 14, 2033

Last Updated

3 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

Area under the curve (AUC)

Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days

Secondary Outcomes

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)