Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

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

Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

Inclusion Criteria:

• Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:

  • 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 infections

• Patients must be expected to require at least 7 days of intravenous antibiotic treatment.

Exclusion Criteria:

• Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
• 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.