Randomized comparison of linezolid (PNU-100766) versus oxacillin-dicloxacillin for treatment of complicated skin and soft tissue infections

This randomized, double-blind, multicenter trial compared the efficacy and safety of linezolid, an oxazolidinone, with those of oxacillin-dicloxacilli n in patients with complicated skin and soft tissue infections. A total of 826 hospitalized adult patients were randomized to receive linezolid (600 m g intravenously [i.v.]) every 12 h or oxacillin (2 g i.v.) every 6 h; follo wing sufficient clinical improvement, patients were switched to the respect ive oral agents (linezolid [600 mg orally] every 12 h or dicloxacillin [500 mg orally] every 6 hours). Primary efficacy variables were clinical cure r ates in both the intent-to-treat (ITT) population and clinically evaluable (CE) patients and microbiological success rate in microbiologically evaluab le (ME) patients. Safety and tolerability were evaluated in the ITT populat ion. Demographics and baseline characteristics were similar across treatmen t groups in the 819 ITT patients. In the ITT population, the clinical cure rates were 69.8 and 64.9% in the linezolid and oxacillin dicloxacillin grou ps, respectively (P = 0.141; 95% confidence interval -1.58 to 11.25). In 29 8 CE linezolid-treated patients, the clinical cure rate was 88.6%, compared with a cure rate of 85.8% in 302 CE patients who received oxacillin-diclox acillin. In 143 ME linezolid-treated patients, the microbiological success rate was 88.1%, compared with a success rate of 86.1% in 151 ME patients wh o received oxacillin-dicloxacillin. Both agents were well tolerated; most a dverse events were of mild-to moderate intensity. No serious drug-related a dverse events were reported in the linezolid group. These data support the use of linezolid for the treatment of adults with complicated skin and soft tissue infections.