Ceftobiprole: A novel broad-spectrum antiinfective

Objective: To review the efficacy, safety, pharmacology, pharmacokinetics, pharmacodynamics, and in vitro microbiology susceptibilities of ceftobiprole, a new broad-spectrum cephalosporin. Data Sources: A PubMed and Internet search (2000-September 2007) was conducted, using the key words ceftobiprole, Ro 63-9141, BAL5788, and BAL9141. Cochrane Library and International Pharmaceutical Abstracts (2000-September 2007) were accessed and reference citations from publications identified were reviewed. Study Selection and Data Extraction: All English-language articles identified from the data sources were reviewed. Phase 3 studies were included in the evaluation. Data Synthesis: Two multinational, double-blind, pivotal Phase 3 studies involving more than 1,600 patients have shown ceftobiprole to have in vitro activity against penicillin-resistant Streptococcus pneumoniae, Pseudomonas spp., and methicillin-resistant Staphylococcus aureus (MRSA). In addition, the cure rates associated with ceftobiprole for complicated skin and skin structure infections (cSSSI) were comparable with those of a single drug or a 2-drug comparator combination. Adverse effects included nausea, vomiting, taste disturbance, headache, and diarrhea. Conclusions: Ceftobiprole is an essential addition to the antimicrobial armamentarium for use against MRSA and/or multidrug-resistant gram-negative infections. Ceftobiprole is approved for the treatment of cSSSI, including diabetic foot infections; however, studies related to the treatment of hospital-acquired and community-acquired pneumonia requiring hospitalization are ongoing. The safety profile is consistent with that of the cephalosporin class of antibiotics. Ceftobiprole will serve as empiric or definitive antimicrobial therapy for resistant gram-negative and gram-positive pathogens. The challenge will be to maintain judicious use through antibiotic stewardship programs and deescalation strategies.