Safety and efficacy of oral and/or intravenous tedizolid phosphate from a randomized phase 3 trial in adolescents with acute bacterial skin and skin structure infections
The Pediatric Infectious Disease Journal Jan 13, 2021
Bradley JS, Antadze T, Ninov B, et al. - In this randomized, assessor-blind, global phase 3 study, researchers sought to compare the safety and effectiveness of tedizolid (administered as tedizolid phosphate) with active antibacterial comparators for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) in adolescents. Of the 121 candidates (12 to < 18 years of age) enlisted, 120 were treated (tedizolid, n = 91; comparator, n = 29). Enrolled candidates were stratified by region and randomized 3:1 to receive tedizolid phosphate 200 mg (oral and/or intravenous) once daily for 6 days or an active comparator, chosen by the investigator from an allowed list per local standard of care, for 10 days. Tedizolid showed safety and efficacy comparable to comparators for the treatment of ABSSSIs in adolescents.
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