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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