Pharmacokinetics of Drugs Administered to Children

NCT ID: NCT03481881

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-14
• Study Completion Date: 2033-08-14

Brief 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.

Conditions

Pediatric ALL

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel G Greenberg, MD

Role: CONTACT

rachel.greenberg@duke.edu

9196684725

Facility Contacts

Rachel Greenberg, MD

Role: primary

rachel.greenberg@duke.edu

919-668-4725

Other Identifiers

Pro00042519

Identifier Type: -

Identifier Source: org_study_id