TEFLARO ABSSSI study design in the pediatric population ages 2 months to less than 18 years1, 4 | |
Type of trial: | Randomized, multicenter, multinational, parallel-group, active-controlled trial |
Primary endpoint: | To evaluate the safety and tolerability of TEFLARO |
Study population: | 163 children 2 months to less than 18 years old with documented ABSSSI |
Comparative agents: |
TEFLARO was compared to vancomycin or cefazolin (each with optional aztreonam). The dose of TEFLARO was adjusted for patient age and weight and delivered via a 60-minute infusion every 8 hours; patients less than 6 months old received 8 mg/kg; patients aged 6 months and older received 12 mg/kg for those weighing 33 kg or less; or 400 mg for those weighing more than 33 kg.* Vancomycin 15 mg/kg infused over 60 minutes or more (or a maximum of 10 mg per minute, whichever was longer) every 6 hours. Cefazolin 75 mg/kg/day divided and infused over 60 minutes every 8 hours. Aztreonam 30 mg/kg infused over 60 minutes every 8 hours. A switch to oral therapy with either cephalexin, clindamycin, or linezolid after Study Day 3 was allowed. |
Treatment duration: | 5 to 14 days (IV therapy with or without oral therapy). |
Study Populations | |
Intent-to-treat (ITT): | All randomized patients. |
Modified Intent-to-treat (MITT): | All randomized patients who received any amount of IV study drug and who had a confirmed diagnosis of ABSSSI. |
Safety: | All randomized patients who received any amount of the study drug. |
TEFLARO ABSSSI study design in the pediatric population ages 2 months to less than 18 years1, 4 |
Type of trial:
Randomized, multicenter, multinational, parallel-group, active-controlled trial Primary Endpoint:To evaluate the safety and tolerability of TEFLARO Study population:163 children 2 months to less than 18 years old with documented ABSSSI Comparative agents:TEFLARO was compared to vancomycin or cefazolin (each with optional aztreonam). The dose of TEFLARO was adjusted for patient age and weight and delivered via a 60-minute infusion every 8 hours; patients less than 6 months old received 8 mg/kg; patients aged 6 months and older received 12 mg/kg for those weighing 33 kg or less; or 400 mg for those weighing more than 33 kg.* Vancomycin 15 mg/kg infused over 60 minutes or more (or a maximum of 10 mg per minute, whichever was longer) every 6 hours. Cefazolin 75 mg/kg/day divided and infused over 60 minutes every 8 hours. Aztreonam 30 mg/kg infused over 60 minutes every 8 hours. A switch to oral therapy with either cephalexin, clindamycin, or linezolid after Study Day 3 was allowed. Treatment duration:5 to 14 days (IV therapy with or without oral therapy).1 Study Populations Intent-to-treat (ITT): All randomized patients Modified Intent-to-treat (MITT):All randomized patients who received any amount of IV study drug and who had a confirmed diagnosis of ABSSSI. Safety:All randomized patients who received any amount of the study drug. |
The doses of ceftaroline fosamil were based on pediatric population pharmacokinetic modeling designed to achieve the same antibiotic exposure in children that was shown to be effective in adults.4
An additional single study enrolled 11 pediatric patients with a gestational age of ≥34 weeks and a postnatal age of 12 days to less than 2 months of age with known or suspected infections. The majority of patients (8 of 11) received 6 mg/kg TEFLARO every 8 hours as an intravenous (IV) infusion over 60 minutes.1
Learn about TEFLARO dosing in pediatric patients based on age and weight
SEE DOSINGPlease also see full Prescribing Information.
Please also see full Prescribing Information.