Pharmacokinetics of Drugs Administered to Children

Pediatric ALL Clinical Trial

Official title:

Pharmacokinetics of Drugs Administered to Children Per Standard of Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481881
• Other study ID #: Pro00042519
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Pediatric ALL

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