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Ceftaroline

A Novel Broad-Spectrum Cephalosporin with Activity against Meticillin-Resistant Staphylococcus aureus

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Abstract

Ceftaroline is a broad-spectrum cephalosporin currently under clinical investigation for the treatment of complicated skin and skin-structure infections (cSSSI), including those caused by meticillin-resistant Staphylococcus aureus (MRSA), and community-acquired pneumonia (CAP). Ceftaroline has the ability to bind to penicillin-binding protein (PBP)2a, an MRSA-specific PBP that has low affinity for most other β-lactam antibacterials. The high binding affinity of ceftaroline to PBP2a (median inhibitory concentration 0.90 μg/mL) correlates well with its low minimum inhibitory concentration for MRSA. Ceftaroline is active in vitro against Gram-positive cocci, including MRSA, meticillin-resistant Staphylococcus epidermidis, penicillin-resistant Streptococcus pneumoniae and vancomycin-resistant Enterococcus faecalis (not E. faecium). The broad-spectrum activity of ceftaroline includes many Gram-negative pathogens but does not extend to extended-spectrum β-lactamase-producing or AmpC-derepressed Enterobacteriaceae or most nonfermentative Gram-negative bacilli. Ceftaroline demonstrates limited activity against anaerobes such as Bacteroides fragilis and non-fragilis Bacteroides spp. Limited data show that ceftaroline has a low propensity to select for resistant subpopulations.

Ceftaroline fosamil (prodrug) is rapidly converted by plasma phosphatases to active ceftaroline. For multiple intravenous doses of 600 mg given over 1 h every 12 hours for 14 days, the maximum plasma concentration was 19.0 μg/mL and 21.0 μg/mL for first and last dose, respectively. Ceftaroline has a volume of distribution of 0.37 L/kg (28.3 L), low protein binding (<20%) and a serum half-life of 2.6 hours. No drug accumulation occurs with multiple doses and elimination occurs primarily through renal excretion (49.6%). Based on Monte Carlo simulations, dosage adjustment is recommended for patients with moderate renal impairment (creatinine clearance 30–50 mL/min); no adjustment is needed for mild renal impairment.

Currently, limited clinical trial data are available for ceftaroline. A phase II study randomized 100 patients with cSSSI to intravenous ceftaroline 600 mg every 12 hours or intravenous vancomycin 1 g every 12 hours with or without intravenous aztreonam 1 g every 8 hours (standard therapy) for 7–14 days. Clinical cure rates were 96.7% for ceftaroline compared with 88.9% for standard therapy. Adverse events were similar between groups and generally mild in nature. In a phase III trial, 702 patients with cSSSI were randomized to ceftaroline 600 mg or vancomycin 1 g plus aztreonam 1 g, each administered intravenously every 12 hours for 5–14 days. Ceftaroline was noninferior to vancomycin plus aztreonam in treating cSSSI caused by both Gram-positive and -negative pathogens. Adverse event rates were similar between groups.

Ceftaroline is well tolerated, which is consistent with the good safety and tolerability profile of the cephalosporin class. In summary, ceftaroline is a promising treatment for cSSSI and CAP, and has potential to be used as monotherapy for polymicrobial infections because of its broad-spectrum activity. Further clinical studies are needed to determine the efficacy and safety of ceftaroline, and to define its role in patient care.

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Acknowledgements

The authors would like to thank Mary Tarka for secretarial assistance. Editorial assistance was provided by Scientific Therapeutics Information, Inc., Springfield, New Jersey, USA, and was funded by Forest Laboratories, Inc., New York, USA. No financial support was received for authorship of this article. The authors have declared that they have no conflicts of interest that are directly relevant to the content of this review.

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Authors and Affiliations

  1. Department of Medical Microbiology, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada

    George G. Zhanel, Grace Sniezek, Frank Schweizer, Philippe R. S. Lagacé-Wiens, Ethan Rubinstein, Alfred S. Gin, Daryl J. Hoban & James A. Karlowsky

  2. Department of Chemistry, Faculty of Science, University of Manitoba, Winnipeg, Manitoba, Canada

    Frank Schweizer

  3. Faculty of Pharmacy, University of Manitoba, Winnipeg, Manitoba, Canada

    Grace Sniezek, Sheryl Zelenitsky & Alfred S. Gin

  4. Department of Medicine, Health Sciences Centre, Winnipeg, Manitoba, Canada

    George G. Zhanel & Ethan Rubinstein

  5. Department of Pharmacy, Health Sciences Centre, Winnipeg, Manitoba, Canada

    Alfred S. Gin

  6. Department of Clinical Microbiology, Health Sciences Centre, Winnipeg, Manitoba, Canada

    Philippe R. S. Lagacé-Wiens, Daryl J. Hoban & James A. Karlowsky

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  1. George G. Zhanel
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Zhanel, G.G., Sniezek, G., Schweizer, F. et al. Ceftaroline. Drugs 69, 809–831 (2009). https://doi.org/10.2165/00003495-200969070-00003

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