NCT00228982

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 784 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Skin Diseases, Infectious
• Skin Diseases, Bacterial
• Staphylococcal Skin Infections

Interventions

Type	Name	Description
DRUG	Ceftobiprole medocaril
DRUG	Vancomycin

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2005-09-29
• Last updated: 2012-07-26