Trial | NCT00228982  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    784
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.
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 Started
Oct 31
2004
Primary Completion
Dec 31
2005
Study Completion
Dec 31
2005
Last Update
Jul 26
2012
Estimate

Drug Ceftobiprole medocaril

Drug Vancomycin

Ceftobiprole medocaril Experimental

Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d

Vancomycin Active Comparator

Vancomycin 1g q12h as 1h infusion, 7-14d

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
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.
No Results Posted