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Ceftobiprole vs. Vancomycin for Complicated Skin Infections
In patients with complicated skin infections, outcomes were similar for ceftobiprole (a broad-spectrum cephalosporin with activity against MRSA) and vancomycin.
Complicated skin and soft-tissue infections caused by gram-positive bacteria are on the rise worldwide. Because of the increasing role played by resistant pathogens, particularly methicillin-resistant Staphylococcus aureus (MRSA), physicians often must resort to antibiotics previously considered "second-line." Ceftobiprole, an investigational pyrrolidinone cephalosporin, has good activity against major gram-negative and gram-positive bacteria, including MRSA, and therefore seems well suited for treating skin infections.
Investigators recently reported the results of an industry-sponsored, double-blind, multinational, phase III trial comparing ceftobiprole (500 mg) with vancomycin (1000 mg), both administered intravenously twice daily, in patients with complicated skin or soft-tissue infections. Of 784 patients randomized, 48% had abscesses, 33% had wounds, and 18% had cellulitis. Approximately 80% of the gram-positive bacteria isolated were S. aureus, of which one third were MRSA. In both study arms, the mean duration of treatment was 9.2 days.
Of 559 evaluable patients, 93% in the ceftobiprole group and 94% in the vancomycin group were considered clinically cured 7 to 14 days after the end of treatment. Clinical cure rates for patients with MRSA infections were also similar between groups (92% and 90%, respectively). Among the 62 patients with gram-negative infections at baseline, the clinical cure rate was better in the ceftobiprole group than in the vancomycin group (81% vs. 47%; P<0.01). Incidences of adverse events and serious adverse events were similar between treatment arms. The most common side effects in ceftobiprole recipients were nausea (14%), taste disturbance (8%), and vomiting (7%).
Comment: New antibiotics with activity against resistant gram-positive pathogens are urgently needed, and ceftobiprole appears to be one of the most promising candidates. Results are eagerly awaited from trials with this agent in other infections in which MRSA and other resistant gram-positive bacteria play a major role.
Published in Journal Watch Infectious Diseases January 30, 2008
Citation(s):
Noel GJ et al. Results of a double-blind, randomized trial of ceftobiprole treatment of complicated skin and skin structure infections caused by gram-positive bacteria. Antimicrob Agents Chemother 2008 Jan; 52:37.
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