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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Staphylococcal Skin Infection

Intervention / Treatment
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* Drug: Telavancin
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telavancin<br> | Drug: Telavancin<br>* Telavancin 10 mg/kg/day, IV for up to 14 days.<br>* Other names: TD-6424;|
| Active Comparator: Vancomycin<br> | Drug: Vancomycin<br>* Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response | The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome. | 7 to 14 days after the last antibiotic dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cSSSI (complicated Skin and Skin Structure Infections), Staph (Staphylococcus), MRSA (Methicillin-resistant Staphylococcus Aureus)