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

Study Overview
=================
Brief Summary
-----------------
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. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in patients with complicated skin and skin structure infections.

Detailed Description
-----------------
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 patients can be treated as in-patient, out-patient, or through a home agency, at the discretion of the investigator. 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
-----------------
A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

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

Intervention / Treatment
-----------------
* Drug: ceftobiprole medocaril
* Drug: Vancomycin plus Ceftazidime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of an infection consistent with complicated skin and skin structure infections. Exclusion Criteria: Known or suspected hypersensitivity to any study medication or other related anti-infective 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vancomycin plus Ceftazidime<br>Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d | Drug: Vancomycin plus Ceftazidime<br> <br> |
| Experimental: Ceftobiprole medocaril<br>Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d | Drug: ceftobiprole medocaril<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7-14 days after the end of therapy. | 7-14 days treatment, test of cure assessment at 7-14 days after end of treatment, late follow-up 28-35 days after end of treatment | 7 weeks | 

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