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

Phase 3

Completed

• Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial; Staphylococcal Skin Infections
• Interventions: Drug: Vancomycin; Drug: Ceftobiprole medocaril

• Registration Number: NCT00228982
• Lead Sponsor: Basilea Pharmaceutica

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.

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 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).

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-29
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 784

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Vancomycin	Vancomycin 1g q12h as 1h infusion, 7-14d
Ceftobiprole medocaril	Ceftobiprole medocaril	Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d

Primary Outcome Measures

Name	Time	Method
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.	7 weeks

Secondary Outcome Measures

Name	Time	Method
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