Ceftobiprole in Hospital Acquired Pneumonia

Launched by BASILEA PHARMACEUTICA · Sep 13, 2005

Keywords

ClinConnect Summary

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 compar...

Gender

ALL

Eligibility criteria

• 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