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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03481881
Other study ID # Pro00042519
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 14, 2013
Est. completion date August 14, 2033

Study information

Verified date December 2023
Source Duke University
Contact Rachel G Greenberg, MD
Phone 9196684725
Email rachel.greenberg@duke.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 14, 2033
Est. primary completion date August 14, 2033
Accepts healthy volunteers No
Gender All
Age group 0 Years to 20 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the curve (AUC) Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary Maximum concentration (Cmax) Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary Time to achieve maximum concentration (Tmax) Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary Absorption rate constant (ka) Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary Elimination rate constant (kel) Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary Half-life (t1/2) Data will be collected throughout the hospital or outpatient stay up to 90 days
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