Ceftobiprole in Hospital Acquired Pneumonia

• Microbiological eradication rate [ Time Frame: At the TOC visit defined as 7-14 days after the EOT ] [ Designated as safety issue: No ]
• Clinical cure rate [ Time Frame: At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT ] [ Designated as safety issue: No ]
• Microbiological eradication rates [ Time Frame: At the LFU visit defined as 28 to 35 days after the EOT ] [ Designated as safety issue: No ]
• Pneumonia-specific mortality rates [ Time Frame: Within 30 days after randomization ] [ Designated as safety issue: No ]

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.

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 receive 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 (BAP00307) and another similar study (BAP00248, see NCT00229008) 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).

• Drug: 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: 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

• Experimental: 001
  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
  Intervention: Drug: ceftobiprole plus placebo
• Active Comparator: 002
  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
  Intervention: Drug: linezolid plus ceftazidime

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