Pharmacokinetics of Off Label Pediatric Medications

University of North Carolina (UNC)

Status: Enrolling

Conditions: Off Label Use of Medications in Pediatric Patients

Study type: Observational

Funder types: Other

Identifiers

NCT01286519

10-0865

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 day to 8 years old

Volunteers: No 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