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Recruiting NCT03481881

Pharmacokinetics of Drugs Administered to Children

— Observational Pediatric ALL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of care drug.
Who it may be relevant to
Registry conditions: Pediatric ALL. Basic parameters: 0 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pharmacokinetics of Drugs Administered to Children Per Standard of Care

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.

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.

Primary outcome measures

  • Area under the curve (AUC) [Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days]
Secondary outcome measures (5)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Duke University — Durham

Identifiers

NCT: NCT03481881 · Pro00042519

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗