TEFLARO CABP study design in the pediatric population1,4 | |
Type of trial: | Randomized, multicenter, multinational, parallel-group, active-controlled trial. |
Primary endpoint: | To evaluate the safety and tolerability of TEFLARO. |
Study population: | 161 children 2 months to less than 18 years old with a diagnosis of CABP. |
Comparative agents: |
TEFLARO was compared to ceftriaxone (each with optional switch to amoxicillin/clavulanate
on Day 4 at up to 90 mg/kg/day divided equally every 12 hours).
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 of age received 8 mg/kg; patients over 6 months of age received 12 mg/kg for those weighing 33 kg or less; or 400 mg for those weighing more than 33 kg.* The dose of ceftriaxone 75 mg/kg to a maximum of 4 g/day, IV in equally divided doses, each infused over 30 minutes every 12 hours. |
Treatment duration: | 5 to 14 days (IV therapy with or without oral therapy). |
TEFLARO Study Populations | |
Intent-to-treat (ITT): | All randomized patients. |
Modified Intent-to-treat (MITT): | Excluded all patients who did not have a confirmed diagnosis of CABP or those infected with a sole atypical pathogen. |
Clinically Evaluable (CE): | All patients in the MITT population who met the definition of CABP and evaluability criteria. |
Safety: |
Randomized patients who received any amount of the study drug.
|
TEFLARO CABP study design in the pediatric population1,4 |
Type of trial:
Randomized, multicenter, multinational, parallel-group, active-controlled trial. Primary endpoint:To evaluate the safety and tolerability of TEFLARO. Study population:161 children 2 months to less than 18 years with a diagnosis of CABP. Comparative agents:TEFLARO was compared to ceftriaxone (each with optional switch to amoxicillin/clavulanate on Day 4 at up to 90 mg/kg/day divided equally every 12 hours). 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 of age received 8 mg/kg; patients over 6 months of age received 12 mg/kg for those weighing 33 kg or less; or 400 mg for those weighing more than 33 kg.* The dose of ceftriaxone 75 mg/kg to a maximum of 4 g/day, IV in equally divided doses, each infused over 30 minutes every 12 hours. Treatment duration:5 to 14 days (IV therapy with or without oral therapy). TEFLARO Study Populations Intent-to-treat (ITT): All randomized patients. Modified Intent-to-treat (MITT):Excluded all patients who did not have a confirmed diagnosis of CABP or those infected with a sole atypical pathogen. Clinically Evaluable (CE):All patients in the MITT population who met the definition of CABP and the evaluability criteria. Safety: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
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.