"Diabetic foot infections are becoming increasingly difficult to treat," said study author, Gary J. Noel, M.D., Franchise Medical Leader, Anti- Infectives, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "These data suggest that ceftobiprole may be useful as stand-alone therapy for this increasingly common type of complicated skin infection."
The use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections, including diabetic foot infections (without concomitant osteomyelitis, an infection of the bone or bone marrow), is under regulatory review in the United States, Europe, Switzerland, Australia and Canada. These data, along with the regulatory submissions, demonstrate the ongoing commitment of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., to developing novel drugs for the anti-infective market.
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 (500mg IV q8h) or 1g of vancomycin administered intravenously every 12 hours (1g IV q12h) plus 1g of ceftazidime administered intravenously every eight hours (1g IV q8h). Severity of diabetic foot infections among the 257 patients varied. Severity was mild (grade 2) in 27%, moderate (grade 3) in 59%, and severe (grade 4) in 13% of trial patients. Additionally, 67% of patients were microbiologically evaluable. The most common pathogens associated with these infections were MSSA (37%), MRSA (15%), E. cloacae (9%), S. agalactiae (8%), P. mirabilis (8%), and P. aeruginosa (8%).
Ceftobiprole was well tolerat
|SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.|
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