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15 November 2005

Volume 41, Number 10
Clinical Infectious Diseases 2005;41:1407–1415
© 2005 by the Infectious Diseases Society of America. All rights reserved.
1058-4838/2005/4110-0002$15.00
DOI: 10.1086/497271
MAJOR ARTICLE

Randomized, Double‐Blind Comparison of Once‐Weekly Dalbavancin versus Twice‐Daily Linezolid Therapy for the Treatment of Complicated Skin and Skin Structure Infections

Luis E. Jauregui,1

Simon Babazadeh,2

Elyse Seltzer,5

Lisa Goldberg,5

Dainis Krievins,7

Mark Frederick,3

David Krause,5

Igors Satilovs,8

Zilvinas Endzinas,9

Jeffrey Breaux,6 and

William O’Riordan4

1St. Vincent Mercy Medical Center, Toledo, Ohio; 2Crest Clinical Trials, Anaheim, 3Talbert Medical Group, Huntington Beach, and 4eStudy Site, Chula Vista, California; 5Vicuron Pharmaceuticals, King of Prussia, Pennsylvania; 6Gulf Coast Research Associates, Baton Rouge, Louisiana; 7P Stradina University Hospital, Riga, and 8Daugavpils Regional Hospital, Daugavpils, Latvia; and 9Kaunas Medical University Hospital, Kaunas, Lithuania

Background.Dalbavancin, a novel lipoglycopeptide with a pharmacokinetic profile that allows weekly dosing, is active against gram‐positive bacteria, including methicillin‐resistant Staphylococcus aureus (MRSA). The efficacy of dalbavancin for treatment of skin and skin structure infections (SSSIs) was demonstrated in a phase 2 study.

Methods.In a phase 3 noninferiority study, patients with complicated SSSIs, including infections known or suspected to involve MRSA, were randomized (ratio, 2:1) in a double‐blind manner to receive dalbavancin (1000 mg given intravenously on day 1 and 500 mg given intravenously on day 8) or linezolid (600 mg given intravenously or intravenously/orally every 12 h for 14 days). Efficacy was assessed by determining clinical and microbiological responses at the end of therapy and at the test‐of‐cure visit. Relapses were identified by additional follow‐up 1 month later.

Results.MRSA was identified in 51% of patients from whom a pathogen was isolated at baseline. Dalbavancin and linezolid demonstrated comparable clinical efficacy in the clinically evaluable population at the test‐of‐cure visit (88.9% and 91.2% success, respectively). The rate of clinical success at the end of therapy was >90% in both arms. Less than 1.0% of patients in either treatment arm experienced relapse after the test‐of‐cure visit. Both treatments yielded successful microbiological response in excess of 85% among microbiologically evaluable patients at end of therapy and at the test‐of‐cure visit for all pathogens combined, for all S. aureus strains, and for MRSA. Gastrointestinal symptoms were among the most common adverse events in both arms. A higher proportion of patients in the linezolid arm reported adverse events that were judged by the investigator to be probably/possibly related to treatment (dalbavancin arm, 25.4% of subjects; linezolid arm, 32.2% of subjects).

Conclusions.Two doses of dalbavancin (1000 mg given on day 1 followed by 500 mg given on day 8) were as well tolerated and as effective as linezolid given twice daily for 14 days for the treatment of patients with complicated SSSI, including those infected with MRSA.

Received 12 May 2005; accepted 8 July 2005; electronically published 6 October 2005.

Reprints or correspondence: Dr. Elyse Seltzer, Vicuron Pharmaceuticals, 455 S. Gulph Rd., Ste. 310, King of Prussia, PA 19406 ().

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  • Members of the Dalbavancin Complicated Skin and Skin Structure Infection Study Group are listed at the end of the text.

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