Recruiting

Drugs in Children

Sponsor:

Duke University

Code:

NCT03481881

Conditions

Pediatric ALL

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

Interventions

Standard of care drug

Study Details

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 ID

NCT03481881

Start date

Aug 14, 2013

Status verified date

Jan, 2026

Completion date

Aug 14, 2033

Anticipated

Primary completion date

Aug 14, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rachel G Greenberg, MD

9196684725rachel.greenberg@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Rachel Greenberg, MD

919-668-4725rachel.greenberg@duke.edu

More Information

Sponsor

Duke University

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-07.