Pharmacokinetics of Off Label Pediatric Medications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-8
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lack of consent
Trial 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
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
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.2
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.
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.3
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.
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.4
Plasma Clearance
the rate at which the drug is eliminated from the body divided by the plasma concentration.
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.Sponsors and contacts
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Source ClinicalTrials.gov