Pharmacokinetics of Off Label Pediatric Medications

Recruiting

• Conditions: Off Label Use of Medications in Pediatric Patients

• Registration Number: NCT01286519
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

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Exclusion Criteria

• Lack of consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC)	approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication.	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.
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.	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.
Terminal elimination rate constant (Ke) and Half-Life	approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.	Period of time that it takes for the concentration of the drug in the body to be reduced by on-half.
Plasma Clearance	approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.	the rate at which the drug is eliminated from the body divided by the plasma concentration.

Trial Locations

Locations (1)

University of North Carolina NC Children's Hospital; 🇺🇸 Chapel Hill, North Carolina, United States