NCT00326287

Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 638 (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 (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.

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 community-acquired pneumonia. 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 community-acquired pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. Patients who meet specified criteria may be switched to an alternative oral treatment. The primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Ceftobiprole medocaril
DRUG	Ceftriaxone with or without Linezolid

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-05-16
• Last updated: 2012-08-02