Ceftobiprole in Hospital Acquired Pneumonia

Phase 3

Completed

Interventions: Drug: ceftobiprole plus placebo
Drug: linezolid plus ceftazidime

Brief Summary: 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: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
001	ceftobiprole plus placebo	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
002	linezolid plus ceftazidime	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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