Pharmacokinetics of Drugs Administered to Children

Pharmacokinetics of Drugs Administered to Children Per Standard of Care

Sponsors

Lead Sponsor: Duke University

Source 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.

Overall Status Recruiting
Start Date August 14, 2013
Completion Date August 14, 2023
Primary Completion Date August 14, 2023
Study Type Observational
Primary Outcome
Measure Time Frame
Area under the curve (AUC) Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary Outcome
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
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Standard of care drug

Description: 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.

Eligibility

Sampling Method: Non-Probability Sample

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)

Gender: All

Minimum Age: N/A

Maximum Age: 20 Years

Healthy Volunteers: No

Overall Contact

Last Name: Rachel G Greenberg, MD

Phone: 9196684725

Email: [email protected]

Location
Facility: Status: Contact: Duke University Rachel Greenberg, MD 919-668-4725 [email protected]
Location Countries

United States

Verification Date

January 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov