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February 13, 2013

Antibiotics for Skin Infections: New Study Design and a Step Toward Shorter Course Therapy

Author Affiliations

Author Affiliations: Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.

JAMA. 2013;309(6):609-611. doi:10.1001/jama.2013.604

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.