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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms
Clinical Infectious Diseases, Volume 46, No. 11, Year 2008
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Description
Background. Telavancin is an investigational, rapidly bactericidal lipoglycopeptide with a multifunctional mechanism of action. Methods. We conducted 2 parallel, randomized, double-blind, active-control, phase 3 studies with a prespecified pooled analysis design. Patients aged ≥18 years who had complicated skin and skin-structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin (10 mg/kg intravenously every 24 h) or vancomycin (1 g intravenously every 12 h). Results. A total of 1867 patients were randomized and received ≥1 dose of study medication. In the clinically evaluable population, at 7-14 days after receipt of the last antibiotic dose, success was achieved in 88% and 87% of patients who received telavancin and vancomycin, respectively (95% confidence interval for the difference, -2.1 to 4.6). Methicillin-resistant Staphylococcus aureus was isolated at baseline from samples from 579 clinically evaluable patients. Among these patients with methicillin-resistant S. aureus infection, cure rates were 91% among patients who received telavancin and 86% among patients who received vancomycin (95% confidence interval for the difference, -1.1 to 9.3). Microbiologic eradication among patients infected with methicillin-resistant S. aureus was 90% in the telavancin treatment group and 85% in the vancomycin treatment group (95% confidence interval for the difference, -0.9 to 9.8). Therapy was discontinued because of adverse events in 8% and 6% of patients who received telavancin and vancomycin, respectively. Except for mild taste disturbance, nausea, vomiting, and serum creatinine concentration elevation in the telavancin treatment group and pruritus in the vancomycin treatment group, adverse events were similar between groups with regard to type and severity. Conclusions. Telavancin given once daily is at least as effective as vancomycin for the treatment of patients with complicated skin and skin-structure infections, including those infected with methicillin-resistant S. aureus. © 2008 by the Infectious Diseases Society of America. All rights reserved.
Authors & Co-Authors
Stryjewski, Martín E.
United States, Durham
Duke University Medical Center
Argentina, Buenos Aires
Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno
Graham, Donald R.
United States, Springfield
Springfield Clinic
Wilson, Samuel E.
United States, Irvine
Uci School of Medicine
O'Riordan, William D.
United States, San Diego
Estudysite
Young, David M.
United States, San Francisco
University of California, San Francisco
Lentnek, Arnold
United States, Marietta
Wellstar Health System
Ross, Douglas Patrick
South Africa, Durban
St. Mary's Hospital
Fowler, Vance G.
United States, Durham
Duke University Medical Center
Hopkins, Alan
United States, San Francisco
Theravance, Inc.
Friedland, Hillel David
United States, San Francisco
Theravance, Inc.
Barriere, Steven L.
United States, San Francisco
Theravance, Inc.
Kitt, Michael M.
United States, San Francisco
Theravance, Inc.
Corey, Gordon Ralph
United States, Durham
Duke University Medical Center
Statistics
Citations: 277
Authors: 13
Affiliations: 9
Identifiers
Doi:
10.1086/587896
ISSN:
10584838
Research Areas
Disability
Study Design
Cross Sectional Study