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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cumberland Pharmaceuticals; Theravance Biopharma Antibiotics, Inc.
• Treatments: Methicillin; Telavancin; Vancomycin

Criteria

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.