Pharmacokinetics of Drugs Administered to Children

December 7, 2023 updated by: Duke University

Pharmacokinetics of Drugs Administered to Children Per Standard of Care

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum concentration (Cmax)
Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Data will be collected throughout the hospital or outpatient stay up to 90 days
Time to achieve maximum concentration (Tmax)
Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Data will be collected throughout the hospital or outpatient stay up to 90 days
Absorption rate constant (ka)
Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Data will be collected throughout the hospital or outpatient stay up to 90 days
Elimination rate constant (kel)
Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Data will be collected throughout the hospital or outpatient stay up to 90 days
Half-life (t1/2)
Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Data will be collected throughout the hospital or outpatient stay up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2013

Primary Completion (Estimated)

August 14, 2033

Study Completion (Estimated)

August 14, 2033

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00042519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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