Pharmacokinetics of Off Label Pediatric Medications

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01286519

Enrollment

400

Registered

2011-01-31

Start date

2010-07-01

Completion date

2035-12-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Off Label Use of Medications in Pediatric Patients

Keywords

pharmacokinetics

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 8 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTSneha Makhijani, BS

sneha_makhijani@med.unc.edu(984) 974-7865

PRINCIPAL_INVESTIGATORMatthew M. Laughon, MD, MPH

University of North Carolina

Outcome results