Status:
COMPLETED
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
Lead Sponsor:
Cumberland Pharmaceuticals
Conditions:
Staphylococcal Skin Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
862 Patients enrolled
Trial Details
Trial ID
NCT00091819
Start Date
January 1 2005
End Date
June 1 2006
Last Update
January 16 2019
Active Locations (1)
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1
Paradise Valley Hospital, 2400 E. 4th Street
National City, California, United States, 91950