Ceftobiprole in Hospital 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 of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.

Detailed Description
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Ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00248) and another similar study (BAP00307, see NCT00210964) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248 Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).

Official Title
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A Phase 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: ceftobiprole plus placebo
* Drug: linezolid plus ceftazidime


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia 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, and have a negative serum or urine pregnancy test at the screening Exclusion Criteria: Known or suspected hypersensitivity to any related antibiotic medications Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information Treatment with any investigational drug within 30 days before enrollment Prior enrollment to this study

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>ceftobiprole plus placebo ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days | Drug: ceftobiprole plus placebo<br>* ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days<br>|
| Active Comparator: 002<br>linezolid plus ceftazidime linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days | Drug: linezolid plus ceftazidime<br>* linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) |  | 7 to 14 days after the end of therapy (EOT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological eradication rate |  | At the TOC visit defined as 7-14 days after the EOT | 
| Clinical cure rate |  | At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT | 
| Microbiological eradication rates |  | At the LFU visit defined as 28 to 35 days after the EOT | 
| Pneumonia-specific mortality rates |  | Within 30 days after the randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ceftobiprole medocaril, Nosocomial Pneumonia, Ventilator-Associated Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus