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news.Johnson & Johnson has reported results from a Phase III trial showing that its investigational antibiotic ceftobiprole was found to clinically cure 86% of patients with diabetic foot infections including some infections that were caused by methicillin-resistant staphylococcus aureus.
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In a Phase III, multi-center, double-blind trial, 257 patients with diabetic foot infections without concomitant osteomyelitis were randomized to receive either 500mg of ceftobiprole administered intravenously every eight hours or 1g of vancomycin administered intravenously every 12 hours plus 1g of ceftazidime administered intravenously every eight hours.
In clinically evaluable patients, 500 mg of ceftobiprole administered intravenously every eight hours demonstrated an 86.2% cure rate compared to an 81.8% cure rate seen with the combination of 1g of vancomycin administered intravenously every 12 hours plus 1g of ceftazidime administered intravenously every eight hours.
Ceftobiprole was well tolerated and the incidence of adverse events in ceftobiprole-treated patients was similar to those observed in the vancomycin plus ceftazidime-treated patients.
These data were presented at the 45th annual meeting of the Infectious Disease Society of America in San Diego, California. Ceftobiprole is licensed from, and is being co-developed with, Basilea Pharmaceutica.
Ceftobiprole belongs to a class of antibacterial agents known as cephalosporins, which are used to treat serious infections caused by Gram- negative and Gram-positive bacteria.
Gary Noel, franchise medical leader, Johnson & Johnson Pharmaceutical, said: “Diabetic foot infections are becoming increasingly difficult to treat. These data suggest that ceftobiprole may be useful as stand-alone therapy for this increasingly common type of complicated skin infection.”