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:February 2005
End Date:May 2006

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Trial Summary
Trial Overview
Inclusion Criteria

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.
We found this trial at
1
site
Louisiana State University Health Sciences Center, Dept of Med/ER Med
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
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