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Antimicrobial Agents and Chemotherapy, December 2000, p. 3408-3413, Vol. 44, No. 12
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Randomized Comparison of Linezolid (PNU-100766) versus Oxacillin-Dicloxacillin for Treatment of Complicated Skin and Soft Tissue Infections

Dennis L. Stevens,1,2,* Leon G. Smith,3 Jon B. Bruss,4 Maureen A. McConnell-Martin,4 Sue E. Duvall,4 Wesley Mark Todd,4 and Barry Hafkin4 for the Linezolid Skin and Soft Tissue Infections Study Group

Infectious Diseases Section, Veterans Administration Medical Center, Boise, Idaho1; University of Washington School of Medicine, Seattle, Washington2; Saint Michael's Medical Center, Newark, New Jersey3; and Pharmacia & Upjohn, Kalamazoo, Michigan4

Received 14 February 2000/Returned for modification 12 July 2000/Accepted 6 September 2000

This randomized, double-blind, multicenter trial compared the efficacy and safety of linezolid, an oxazolidinone, with those of oxacillin-dicloxacillin in patients with complicated skin and soft tissue infections. A total of 826 hospitalized adult patients were randomized to receive linezolid (600 mg intravenously [i.v.]) every 12 h or oxacillin (2 g i.v.) every 6 h; following sufficient clinical improvement, patients were switched to the respective oral agents (linezolid [600 mg orally] every 12 h or dicloxacillin [500 mg orally] every 6 hours). Primary efficacy variables were clinical cure rates in both the intent-to-treat (ITT) population and clinically evaluable (CE) patients and microbiological success rate in microbiologically evaluable (ME) patients. Safety and tolerability were evaluated in the ITT population. Demographics and baseline characteristics were similar across treatment 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 groups, respectively (P = 0.141; 95% confidence interval -1.58 to 11.25). In 298 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-dicloxacillin. 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 who received oxacillin-dicloxacillin. Both agents were well tolerated; most adverse events were of mild-to-moderate intensity. No serious drug-related adverse 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.

* Corresponding author. Mailing address: Infectious Diseases Section, Bldg. 45, VA Medical Center, 500 W. Fort St., Boise, ID 83702. Phone: (208) 422-1599. Fax: (208) 422-1364. E-mail: dlsteven{at}primenet.com.

Antimicrobial Agents and Chemotherapy, December 2000, p. 3408-3413, Vol. 44, No. 12
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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