Pharmacokinetics of Drugs Administered to Children
ConditionPediatric ALL
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-20
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
Disqualifiers
Failure to obtain consent/assent (as indicated)
Trial population
Children (\<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard of care drug
DrugThis 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Area under the curve (AUC)
Time frame
Data will be collected throughout the hospital or outpatient stay up to 90 daysSecondary outcomes
1
Maximum concentration (Cmax)
Time frame
Data will be collected throughout the hospital or outpatient stay up to 90 days2
Time to achieve maximum concentration (Tmax)
Time frame
Data will be collected throughout the hospital or outpatient stay up to 90 days3
Absorption rate constant (ka)
Time frame
Data will be collected throughout the hospital or outpatient stay up to 90 days4
Elimination rate constant (kel)
Time frame
Data will be collected throughout the hospital or outpatient stay up to 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov