Monotherapy with ceftobiprole was found to be as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin-structure infections caused by gram-positive and gram-negative bacteria.
The Food and Drug Administration granted ceftobiprole fast-track status for the treatment of complicated skin and skin-structure infections caused by methicillin-resistant staphylococci and hospital-acquired pneumonia. Ceftobiprole is a novel, broad-spectrum cephalosporin developed jointly by Basilea Pharmaceutica AG and Cilag AG International, a Johnson & Johnson company.
The randomized, double-blind, multicenter trial included 828 patients with diabetic foot infections, abscess, cellulitis, and wound infection, reported Gary J. Noel and his fellow researchers, all full-time employees of Johnson & Johnson Pharmaceutical Research and Development, Raritan, N.J., which funded the study (Clin. Infect. Dis. 2008;46:647–55).
Infecting pathogen types—identified in at least 10 patients at baseline—included coagulase-negative and coagulase-positive staphylococci, Pseudomonas aeruginosa, β-hemolytic streptococci, and enterobacteriaceae. The most prevalent pathogens were gram-positive bacteria, specifically methicillin-resistant Staphylococcus aureus (MRSA) in 123 patients and methicillin-susceptible S. aureus (MSSA) in 250 patients.
The patient cohort, accumulated over 129 international sites, was divided into two arms, with 547 patients receiving ceftobiprole and 281 receiving the glycopeptide antibiotic vancomycin plus the third-generation cephalosporin ceftazidime. Respectively, the two study arms consisted of 63% and 64% men and had mean ages of 53 years and 52 years. The proportion of patients completing the trial was 92% in the ceftobiprole arm and 90% in the comparator arm.
Patients in the ceftobiprole arm received 500 mg for 120 minutes every 8 hours. In the comparator group, the starting dose was 1,000 mg vancomycin infused over 60 minutes every 12 hours plus 1,000 mg ceftazidime infused over 120 minutes every 8 hours. The mean duration of treatment in the clinically evaluable population was about 9 days in both arms, the authors noted.
At the test-of-cure (TOC) visit (after 6–17 days of treatment) for the evaluable patients, clinical cure occurred for 439 of 485 (91%) ceftobiprole-treated patients and for 220 of 244 (90%) comparator-treated patients, the researchers noted.