Pharmacokinetics of Drugs Administered to Children

NCT03481881 | Recruiting FDA Drug

• 1 other identifier: Pro00042519
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC)

  Data will be collected throughout the hospital or outpatient stay up to 90 days

Secondary Outcomes (5)

• Maximum concentration (Cmax)

  Data will be collected throughout the hospital or outpatient stay up to 90 days

• Time to achieve maximum concentration (Tmax)

  Data will be collected throughout the hospital or outpatient stay up to 90 days

• Absorption rate constant (ka)

  Data will be collected throughout the hospital or outpatient stay up to 90 days

• Elimination rate constant (kel)

  Data will be collected throughout the hospital or outpatient stay up to 90 days

• Half-life (t1/2)

  Data will be collected throughout the hospital or outpatient stay up to 90 days

Interventions

Standard of care drug 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.

Eligibility Criteria

• Age: 0 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children (\<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver

You may qualify if:

• Children (\< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

You may not qualify if:

• Failure to obtain consent/assent (as indicated)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Rachel G Greenberg, MD

CONTACT

9196684725; rachel.greenberg@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 29, 2018
• Study Start: August 14, 2013
• Primary Completion (Estimated): August 14, 2033
• Study Completion (Estimated): August 14, 2033
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)