This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes
This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes in male or female infants, children, and adolescents (\> 12 months to 17 years, inclusive) who require systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection. Blood samples for PK assessment will be taken as follows: 1.0 hour (±5 min), 1.5 hours (±5 min), 2 hours (±5 min), 6 hours (±30 min), 12 hours (±30 min) and 24 hours (±30 minutes) after the beginning of the infusion. The timing of PK sampling may be optimized after the completion of the older age groups (Cohorts 1-3) to assure that the minimum numbers of samples are collected in the youngest age group \> 12months to \< 24 months. Plasma exposures that will be compared to adult exposures are the primary assessment for this study. Subject safety will be monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, concomitant medication usage, and adverse event reporting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Orange County
Orange, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and area under the curve extrapolated to infinity was calculated for the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
Pharmacokinetics- Maximum Plasma Concentration of Telavancin
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin to provide the maximum plasma concentration of telavancin following a single 10 mg/kg IV dose.
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin to provide the time to maximum plasma concentration of telavancin following a single 10 mg/kg IV dose.
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
Pharmacokinetics- Terminal Elimination Half-life for Plasma Telavancin
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and the terminal elimination half-life was calculated from the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
Pharmacokinetics- Area Under the Curve From Time Zero to the Last Sample for the Telavancin Plasma Concentration Versus Time Curve
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and area under the curve from time zero to the last sample was calculated for the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.
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Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
Safety- Number of Treatment-emergent Adverse Events.
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
Time frame: Day 0 (screening) through follow-up on Day 8 (+/- 1 day)
Safety- Number of Subjects With Treatment-emergent Adverse Events
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
Time frame: Day 0 (screening) through follow-up on Day 8 (+/- 1 day)