Pharmacokinetics of Off Label Pediatric Medications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Off Label Use of Medications in Pediatric Patients. Basic parameters: 1 Day — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Area under the curve (AUC) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- University of North Carolina NC Children's Hospital — Chapel Hill
Identifiers
NCT: NCT01286519 · 10-0865