A Phase 3 Study of the Safety and Efficacy of Tedizolid Phosphate in Patients <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections

Abstract

Background: Acute bacterial skin and skin structure infections (ABSSSI) are serious infections of the skin and subcutaneous tissue that include major cutaneous abscesses, cellulitis/erysipelas, and wound infections. ABSSSI caused by Gram-positive pathogens are common in children, who tend to experience high rates of morbidity and hospitalization due to ABSSSI, including those caused by antibacterial-resistant pathogens.

Methods: This phase 3 study (NCT03176134) investigated the safety of tedizolid phosphate and its ability to treat ABSSSI in pediatric participants 28 days to <12 years of age. A total of 100 participants were randomized 3:1 to intravenous and/or oral tedizolid phosphate for 6-10 days or intravenous and/or oral comparator for 10-14 days; participants were stratified and enrolled by age cohort. The primary objective was to evaluate the safety of tedizolid phosphate versus comparators using descriptive statistics. The secondary objective was to evaluate clinical response at the test-of-cure (TOC) visit in the intent-to-treat and clinically evaluable populations.

Results: Tedizolid phosphate was well tolerated, and adverse events were comparable between the tedizolid phosphate and comparator groups. Clinical success rates at the TOC visit in the intent-to-treat and clinically evaluable populations were high (>90%) and comparable between groups. All participants in the tedizolid phosphate treatment group who had skin culture results at baseline experienced favorable microbiological response at the TOC visit.

Conclusions: The results of this study provide evidence to support the use of tedizolid phosphate to treat ABSSSI caused by Gram-positive pathogens in pediatric patients from 28 days to <12 years of age.

Keywords: ABSSSI; Sivextro; pediatric infection; skin infection.