Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | January 2005 |
| End Date: | June 2006 |
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 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.
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 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.
We found this trial at
1
site
Click here to add this to my saved trials
