Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Ceftobiprole medocaril
* Drug: Ceftriaxone with or without Linezolid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftobiprole medocaril<br>Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d | Drug: Ceftobiprole medocaril<br> <br> |
| Active Comparator: Ceftriaxone with or without Linezolid<br>Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d | Drug: Ceftriaxone with or without Linezolid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients) |  | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community-Acquired Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus