A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram positive Skin and Skin Structure Infections with a Focus on Patients with Infections Due to Methicillin resistant Staphylococcus aureus (ATLAS I)

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A large multinational, double-blind, randomized Phase III clinical study designed to compare the efficacy and safety of telavancin (10mg/kg IV once daily) versus vancomycin (1gm IV q12 hr) in adult patients with complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. The primary objective of the study was to compare the efficacy and safety of telavancin to vancomycin in the treatment of adults with complicated Gram positive skin and skin structure infections with an emphasis on patients with infections due to methicillin resistant Staphylococcus aureus (MRSA). A key secondary objective of this study was to pool the data from this study with data from a second study of identical design (Study 0018) and to assess the superiority of telavancin to vancomycin in patients with MRSA infections. Patients were assessed for clinical response by assessing a patient’s signs and symptoms at the specified evaluation compared to their Baseline evaluation. A cure consisted of resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary. Not cured meant there was an inadequate response to study therapy and Indeterminate meant the outcome was not able to be determined.

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