FAST2A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Fecha de inicio: 1 de febrero de 2004

Inclusion Criteria: * Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism * major abscess requiring surgical incision and drainage * infected burn (see exclusion criteria for important qualifications) * deep/extensive cellulitis * infected ulcer (see exclusion criteria for important qualifications) * wound infection * Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment Exclusion Criteria: * Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for \> 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days) * Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis