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May 22, 2013

End Points in Trials of Treatments for Skin Infections

Author Affiliations

Letters Section Editor: Jody W. Zylke, MD, Senior Editor.

Author Affiliation: Los Angeles Biomedical Research Institute, Harbor-University of California at Los Angeles Medical Center, Torrance (bspellberg@labiomed.org).

JAMA. 2013;309(20):2091-2092. doi:10.1001/jama.2013.4541

To the Editor: In accord with US Food and Drug Administration guidance for skin infection clinical trials, Dr Prokocimer and colleagues1 reported an early “cessation of lesion spread” analysis as their primary end point in a trial of tedizolid phosphate vs linezolid for acute bacterial skin and skin structure infections (ABSSSIs). Thus, patients with skin infections were deemed treatment successes if the skin infection did not worsen after receiving antibiotic therapy for 3 days.