Author Affiliations: Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.
In this issue of JAMA, Prokocimer et al1 present the results of ESTABLISH-1 (Efficacy and Safety of 6-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs 10-day Oral Linezolid Therapy), an international, multicenter, double-blind, phase 3, noninferiority trial comparing a 6-day course of oral tedizolid phosphate once daily with a 10-day course of oral linezolid twice daily for treatment of acute bacterial skin and skin structure infections (ABSSSIs). Among 667 adults with ABSSSIs randomized to treatment with tedizolid phosphate (n = 332) or linezolid (n = 335), the early clinical treatment response rates were 79.5% with tedizolid phosphate and 79.4% with linezolid, a treatment difference of 0.1% (95% CI, −6.1% to 6.2%). The sustained clinical treatment response rates at the end of treatment (day 11) were 69.3% with tedizolid phosphate and 71.9% with linezolid (a treatment difference of −2.6% [95% CI, −9.6% to 4.2%]), with the lower bounds of the 95% confidence intervals within the prespecified 10% noninferiority margin. The authors concluded that tedizolid phosphate was statistically noninferior to linezolid in achieving early clinical response after initiating therapy for ABSSSI.
Doron S, Boucher HW. Antibiotics for Skin InfectionsNew Study Design and a Step Toward Shorter Course Therapy. JAMA. 2013;309(6):609-611. doi:10.1001/jama.2013.604