Ceftobiprole in Hospital Acquired Pneumonia

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

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 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).

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