Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

Phase 3

Completed

• Conditions: Pneumonia
• Interventions: Drug: Ceftriaxone with or without Linezolid; Drug: Ceftobiprole medocaril

• Registration Number: NCT00326287
• Lead Sponsor: Basilea Pharmaceutica

Brief 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.

Study Timeline

• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-16
• Study Start: 2006-06
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Disposition First Submitted: 2011-06-03
• Disposition First Submitted QC: 2011-06-03
• Disposition First Posted: 2011-06-16
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 638

Inclusion Criteria

• Patients suffering from community-acquired pneumonia severe enough to require hospitalization
• Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study

Exclusion Criteria

• Patients with known or suspected hypersensitivity to any related antibiotic medications
• Treatment with any experimental drug within 30 days before enrollment
• Prior enrollment in this study or any study with ceftobiprole medocaril

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceftriaxone with or without Linezolid	Ceftriaxone with or without Linezolid	Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d
Ceftobiprole medocaril	Ceftobiprole medocaril	Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d

Primary Outcome Measures

Name	Time	Method
Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug	7 weeks

Secondary Outcome Measures

Name	Time	Method
Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)	7 weeks