Pharmacokinetics of Off Label Pediatric Medications

The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.

Study Overview

• Status: Recruiting
• Conditions: Off Label Use of Medications in Pediatric Patients

Detailed Description

There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Jennifer Talbert, MS, RN; Phone Number: (984) 974-7865; Email: jtalbert@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina NC Children's Hospital
      • Contact: Jennifer Talbert, MS, RN; Phone Number: 984-974-7865; Email: jtalbert@med.unc.edu
      • Principal Investigator: Matthew M Laughon, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 8 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

children < 8 years of age currently receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care

Description

Inclusion Criteria:

• Children less than 8 years of age
• Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care

Exclusion Criteria:

• Lack of consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC)	actual body exposure to drug after a dose of the drug is administered. this is dependent on on the rate of drug elimination divided by plasma concentration of the drug.	approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.
Volume of distribution at steady-state	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.	approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Terminal elimination rate constant (Ke) and Half-Life	Period of time that it takes for the concentration of the drug in the body to be reduced by on-half.	approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.
Plasma Clearance	the rate at which the drug is eliminated from the body divided by the plasma concentration.	approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Matthew M. Laughon, MD, MPH, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Anticipated): December 1, 2035
• Study Completion (Anticipated): December 1, 2035

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 28, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pharmacokinetics
• Other Study ID Numbers: 10-0865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO