Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS1)

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Staphylococcal Skin Infection

Treatments: Drug: Telavancin; Drug: Vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00091819

0017

Details and patient eligibility

About

Study 0017 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.

Enrollment: 862 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have a diagnosis of one of the following complicated skin and skin structure infections with Methicillin Resistant Staphylococcus aureus (MRSA) 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 prior to randomization
• Burns involving > 20% of body surface area or third-degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fascitis, gas gangrene, or mediastinitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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862 participants in 2 patient groups

Telavancin

Experimental group

Treatment:

Drug: Telavancin

Vancomycin

Active Comparator group

Treatment:

Drug: Vancomycin