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NCT Number: NCT03481881

Pharmacokinetics of Drugs Administered to Children

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.

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Key information

Conditions

Pediatric ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

0 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Rachel Greenberg, MD

CONTACT

[email protected]

919-668-4725

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Area under the curve (AUC)

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

Secondary outcomes

  1. Maximum concentration (Cmax)

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

  2. Time to achieve maximum concentration (Tmax)

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

  3. Absorption rate constant (ka)

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

  4. Elimination rate constant (kel)

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

  5. Half-life (t1/2)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel G Greenberg, MD

CONTACT

[email protected]

9196684725

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Pharmacokinetics of Drugs Administered to Children Per Standard of Care

Important dates

Study start
2013
Primary completion
2033
Study completion
2033
First posted
Mar 29, 2018
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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