Pharmacokinetics of Drugs Administered to Children
Recruiting
- Conditions
- Pediatric ALL
- Registration Number
- NCT03481881
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
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Exclusion Criteria
- Failure to obtain consent/assent (as indicated)
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve (AUC) Data will be collected throughout the hospital or outpatient stay up to 90 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States