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Antimicrobial Agents and Chemotherapy, March 2006, p. 862-867, Vol. 50, No. 3
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.3.862-867.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Telavancin versus Standard Therapy for Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: FAST 2 Study

Martin E. Stryjewski,1,2* Vivian H. Chu,1,2 William D. O'Riordan,3,4 Brian L. Warren,5 Lala M. Dunbar,6 David M. Young,7 Marc Vallée,2 Vance G. Fowler Jr.,1,2 Joel Morganroth,8,9 Steven L. Barriere,10 Michael M. Kitt,10 G. Ralph Corey,1,2 for the FAST 2 Investigator Group

Division of Infectious Diseases, Duke University Medical Center,1 Duke Clinical Research Institute, Durham, North Carolina,2 Paradise Valley Hospital, National City,3 e-StudySite, San Diego, California,4 Department of Surgery, Tygerberg Hospital and University of Stellenbosch, Tygerberg, South Africa,5 Louisiana State University Medical Center, New Orleans, Louisiana,6 San Francisco General Hospital/UCSF, San Francisco, California,7 University of Pennsylvania School of Medicine,8 eResearchTechnology, Inc., Philadelphia, Pennsylvania,9 Theravance, Inc., South San Francisco, California,10

Received 1 July 2005/ Returned for modification 4 August 2005/ Accepted 9 December 2005

Telavancin is a bactericidal lipoglycopeptide with a multifunctional mechanism of action. We conducted a randomized, double blind, active-control phase II trial. Patients ≥18 years of age with complicated skin and skin structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin at 10 mg/kg intravenously every 24 h (q24h) or standard therapy (antistaphylococcal penicillin at 2 g q6h or vancomycin at 1 g q12h). A total of 195 patients were randomized and received at least one dose of study medication. Clinical success rates were similar in all analysis populations at test of cure. In microbiologically evaluable patients with Staphylococcus aureus at baseline (n = 91), 96% of the telavancin group and 90% of the standard-therapy group were cured. Among patients with methicillin-resistant S. aureus (MRSA) at baseline (n = 45), clinical cure rates were also 96% for telavancin and 90% for standard therapy. Microbiologic eradication in patients with S. aureus infection was better with telavancin compared to standard therapy (92% versus 78%, P = 0.07) and significantly better in patients with MRSA (92% versus 68%; P = 0.04). Therapy was discontinued for an adverse event (AE) in 6% and 3% of the patients receiving telavancin and standard therapy, respectively. Except for two cases of rash in the telavancin group, these AEs were similar in type and severity in the two groups. The overall incidences and severities of AEs and laboratory abnormalities were similar between the two groups. These data support the ongoing studies assessing the efficacy and safety of telavancin in the treatment of serious gram-positive infections, particularly involving MRSA.

* Corresponding author. Mailing address: Azcuenaga 1757, Apt. 1C, Capital Federal (C1128AAC), Buenos Aires, Argentina. Phone: 54-114-803-1358. Fax: 54-114-803-1358. E-mail: stryj001{at}mc.duke.edu.

Antimicrobial Agents and Chemotherapy, March 2006, p. 862-867, Vol. 50, No. 3
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.3.862-867.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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