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Antimicrobial Agents and Chemotherapy, January 2008, p. 37-44, Vol. 52, No. 1
0066-4804/08/$08.00+0     doi:10.1128/AAC.00551-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Results of a Double-Blind, Randomized Trial of Ceftobiprole Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria{triangledown}

Gary J. Noel,1* Richard S. Strauss,1 Karen Amsler,1 Markus Heep,2 Rienk Pypstra,2 and Joseph S. Solomkin3

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey,1 Basilea Pharmaceutica Ltd., Basel, Switzerland,2 University of Cincinnati College of Medicine, Cincinnati, Ohio3

Received 25 April 2007/ Returned for modification 27 July 2007/ Accepted 12 September 2007

Ceftobiprole is the first broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA) to be assessed in late-stage clinical trials. As a pivotal step in the clinical development of ceftobiprole, a multicenter, global, randomized, double-blind trial was conducted to compare the efficacy of ceftobiprole to that of vancomycin in patients with complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. The primary objective was to assess noninferiority on the basis of the cure rates 7 to 14 days after the completion of therapy in patients administered ceftobiprole 500 mg every 12 h or vancomycin 1 g every 12 h. Of 784 patients randomized, 282 receiving ceftobiprole and 277 receiving vancomycin were clinically evaluable. Of these patients, 93.3% treated with ceftobiprole and 93.5% treated with vancomycin were cured (95% confidence interval of difference, –4.4%, 3.9%). The cure rates for patients with MRSA infections were 91.8% (56/61) with ceftobiprole treatment and 90.0% (54/60) with vancomycin treatment (95% confidence interval of difference, –8.4%, 12.1%). At least one adverse event (AE) was reported by 52% of the ceftobiprole-treated patients and 51% of the vancomycin-treated patients. The most common AEs reported by the ceftobiprole-treated patients were nausea (14%) and taste disturbance (8%). Discontinuation of the study drug because of treatment-emergent AEs occurred in 4% (n = 17) of the ceftobiprole-treated patients and 6% (n = 22) of the vancomycin-treated patients. The results of this trial support the use of ceftobiprole as an effective and well-tolerated treatment option for patients with cSSSIs caused by a spectrum of gram-positive bacteria.

* Corresponding author. Mailing address: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., 900 Route 202, Raritan, NJ 08869. Phone: (908) 704-4316. Fax: (908) 595-0843. E-mail: GNoel1{at}prdus.jnj.com

{triangledown} Published ahead of print on 22 October 2007.

Antimicrobial Agents and Chemotherapy, January 2008, p. 37-44, Vol. 52, No. 1
0066-4804/08/$08.00+0     doi:10.1128/AAC.00551-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.



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