Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.

Detailed Description
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Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Official Title
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A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

Conditions
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Skin Diseases, Infectious, Skin Diseases, Bacterial, Staphylococcal Skin Infections

Intervention / Treatment
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* Drug: Ceftobiprole medocaril
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of an infection consistent with complicated skin and skin structure infections. Exclusion Criteria: Known or suspected hypersensitivity to any study medication Any known or suspected condition or concurrent treatment contraindicated by the prescribing information Previous enrollment in this study Treatment with any investigational drug within 30 days before enrollment.

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: Ceftobiprole medocaril<br>Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d | Drug: Ceftobiprole medocaril<br> <br> |
| Active Comparator: Vancomycin<br>Vancomycin 1g q12h as 1h infusion, 7-14d | Drug: Vancomycin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy. |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological outcome at 7-14 days after the end of therapy. Clinical and microbiological outcome at late follow-up visit. Evolution of signs and symptoms of disease. Time to clinical cure. Safety and tolerability evaluations during the study. |  | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complicated Skin Infections, Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Cephalosporin