End points in trials of treatments for skin infections

摘要

To the Editor: In accord with US Food and Drug Administration guidance for skin infection clinical trials, Dr Prokoc-imer and colleagues reported an early "cessation of lesion spread" analysis as their primary end point in a trial of te-dizolid 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. The authors made an argument for the validity of the end point by writing, "In this trial, there was good concor dance (>80%) between early objective and late investigator-assessed primary end points, suggesting that the early end point is indicative of a sustained and late clinical outcome. Clinical response at early time points . . . appears to be a valid approach. ..." I do not believe that this is correct.