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1 June 2005

Volume 40, Number 11
Clinical Infectious Diseases 2005;40:1601–1607
© 2005 by the Infectious Diseases Society of America. All rights reserved.
1058-4838/2005/4011-0005$15.00
DOI: 10.1086/429914
MAJOR ARTICLE

Telavancin Versus Standard Therapy for Treatment of Complicated Skin and Soft‐Tissue Infections Due to Gram‐Positive Bacteria

Martin E. Stryjewski,1,3

William D. O’Riordan,4,5

William K. Lau,7

Francis D. Pien,8

Lala M. Dunbar,9

Marc Vallee,3

Vance G. Fowler Jr.1,3

Vivian H. Chu,1,3

Elizabeth Spencer,6

Steven L. Barriere,6

Michael M. Kitt,6

Christopher H. Cabell,2,3 and

G. Ralph Corey,1,3 for the

FAST Investigator Group

1Division of Infectious Diseases and 2Cardiology, Duke University Medical Center, and 3Duke Clinical Research Institute, Durham, North Carolina; 4Paradise Valley Hospital, National City, 5 e‐StudySite, San Diego, and 6Theravance Inc., South San Francisco, California; 7St. Francis Hospital and 8Straub Clinic and Hospital, Honolulu, Hawaii; and 9Louisiana State University Medical Center, New Orleans, Louisiana

Background.Telavancin, a novel lipoglycopeptide, exerts concentration‐dependent, rapid bactericidal activity on account of its multiple mechanisms of action. Telavancin is highly active against gram‐positive bacteria, including methicillin‐resistant Staphylococcus aureus (MRSA), vancomycin‐intermediate, and vancomycin‐resistant strains.

Methods.We conducted a randomized, double‐blind, controlled, phase‐2 clinical trial. Patients 18 years of age with a diagnosis of complicated skin and soft‐tissue infection caused by suspected or confirmed gram‐positive organisms were randomized to receive either intravenously administered telavancin once daily or standard therapy (antistaphylococcal penicillin 4 times daily or vancomycin twice daily).

Results.For the study, 167 patients were randomized and received at least 1 dose of study medication. Success rates were similar in all analysis populations at the test‐of‐cure evaluation. Of patients with S. aureus infection at baseline ( ), 80% of the telavancin group were cured and 77% of the standard therapy group were cured. For patients with MRSA infection at baseline ( ), cure rates were 82% for the telavancin group and 69% for the standard therapy group. Microbiologic eradication in patients with MRSA infection was 84% for the telavancin group versus 74% for the standard therapy group. MIC90 values were lower for telavancin in all tested strains of S. aureus (0.25 ug/mL) compared with the MIC90 values for vancomycin and oxacillin. Similar proportions of patients discontinued therapy for adverse events in both treatment groups (5%). Fewer serious adverse events were reported in the telavancin group (4 events) than were for the standard therapy group (9).

Conclusion.Clinical and microbiological results of this study support the further development of telavancin, especially for treatment of infection due to MRSA.

Received 4 November 2004; accepted 25 January 2005; electronically published 28 April 2005.

Reprints or correspondence: Dr. G. Ralph Corey, 2400 Pratt St., Rm. 7030, Duke Clinical Research Institute, Durham, NC 27710 ().

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