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Antimicrobial Agents and Chemotherapy, June 2005, p. 2260-2266, Vol. 49, No. 6
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.6.2260-2266.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Linezolid versus Vancomycin in Treatment of Complicated Skin and Soft Tissue Infections

John Weigelt,1* Kamal Itani,2 Dennis Stevens,3 William Lau,4 Matthew Dryden,5 Charles Knirsch,6* the Linezolid CSSTI Study Group

Medical College of Wisconsin, Milwaukee, Wisconsin,1 Boston VA Health Care System and Boston University, Boston, Massachusetts,2 Veterans Affairs Medical Center, Boise, Idaho,3 St. Francis Medical Center West, Honolulu, Hawaii,4 Royal Hampshire County Hospital, Winchester, Hampshire, United Kingdom,5 Pfizer World Wide Medical, New York, New York6

Received 15 June 2004/ Returned for modification 8 November 2004/ Accepted 4 February 2005

Skin and soft tissue infections (SSTIs) are a common cause of morbidity in both the community and the hospital. An SSTI is classified as complicated if the infection has spread to the deeper soft tissues, if surgical intervention is necessary, or if the patient has a comorbid condition hindering treatment response (e.g., diabetes mellitus or human immunodeficiency virus). The purpose of this study was to compare linezolid to vancomycin in the treatment of suspected or proven methicillin-resistant gram-positive complicated SSTIs (CSSTIs) requiring hospitalization. This was a randomized, open-label, comparator-controlled, multicenter, multinational study that included patients with suspected or proven methicillin-resistant Staphylococcus aureus (MRSA) infections that involved substantial areas of skin or deeper soft tissues, such as cellulitis, abscesses, infected ulcers, or burns (<10% of total body surface area). Patients were randomized (1:1) to receive linezolid (600 mg) every 12 h either intravenously (i.v.) or orally or vancomycin (1 g) every 12 h i.v. In the intent-to-treat population, 92.2% and 88.5% of patients treated with linezolid and vancomycin, respectively, were clinically cured at the test-of-cure (TOC) visit (P = 0.057). Linezolid outcomes (124/140 patients or 88.6%) were superior to vancomycin outcomes (97/145 patients or 66.9%) at the TOC visit for patients with MRSA infections (P < 0.001). Drug-related adverse events were reported in similar numbers in both the linezolid and the vancomycin arms of the trial. The results of this study demonstrate that linezolid therapy is well tolerated, equivalent to vancomycin in treating CSSTIs, and superior to vancomycin in the treatment of CSSTIs due to MRSA.

* Corresponding author. Mailing address for Charles Knirsch: Pfizer Inc., 235 East 42nd Street, Mailstop 235/8/29, New York, NY 10017. Phone: (212) 733-4231. Fax: (212) 973-7379. E-mail: charles.knirsch{at}pfizer.com. Mailing address for John Weigelt: Department of Surgery, Medical College of Wisconsin, 200 W. Wisconsin Ave., Milwaukee, WI 53226. Phone: (414) 805-8636. Fax: (414) 805-8641. E-mail: jweigelt{at}mcw.edu.

Antimicrobial Agents and Chemotherapy, June 2005, p. 2260-2266, Vol. 49, No. 6
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.6.2260-2266.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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