Pharmacokinetics of Drugs Administered to Children
Overview
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.
Full Title of Study: “Pharmacokinetics of Drugs Administered to Children Per Standard of Care”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: August 14, 2033
Interventions
- Drug: 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.
Clinical Trial Outcome Measures
Primary Measures
- Area under the curve (AUC)
- Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary Measures
- Maximum concentration (Cmax)
- Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
- Time to achieve maximum concentration (Tmax)
- Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
- Absorption rate constant (ka)
- Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
- Elimination rate constant (kel)
- Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
- Half-life (t1/2)
- Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Participating in This Clinical Trial
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 Eligibility: All
Minimum Age: 0 Years
Maximum Age: 20 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Duke University
- Provider of Information About this Clinical Study
- Sponsor
- Overall Contact(s)
- Rachel G Greenberg, MD, 9196684725, rachel.greenberg@duke.edu
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