title: Ceftaroline: clinical and microbiology experience with focus on methicillin-resistant Staphylococcus aureus after regulatory approval in the USA.
abstract: Ceftaroline fosamil was approved in 2010 by the United States Food and Drug Administration (USA-FDA) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP). After approval, several studies and case reports have described the postmarketing clinical experience with ceftaroline in ABSSSIs and CABP and in patients with invasive methicillin-resistant Staphylococcus aureus (MRSA) infections, many of whom had failed prior antibiotics. Successful clinical outcomes observed among the majority of these patients were supported by preapproval and postapproval in vitro surveillance of ceftaroline activity using breakpoint criteria that have been harmonized between the USA-FDA and CLSI. MIC90 values/percentage of strains susceptible to ceftaroline has remained stable over the period 2009-2012. Taken together, these postapproval studies support the use of ceftaroline for ABSSSI as well as CABP. Importantly, these data also suggest that ceftaroline can be effective in patients with serious invasive MRSA infections who have failed other therapies.
authors.affiliation: Department of Medicine and Division of Infectious Diseases, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina. Electronic address: stryj001@fibertel.com.ar.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Stryjewski
authors.affiliation: JMI Laboratories, North Liberty, IA, USA.
authors.forename: Ronald N
authors.initials: RN
authors.lastname: Jones
authors.affiliation: Division of Infectious Diseases, Duke Clinical Research Institute, Durham, NC, USA; Duke University Medical Center, Durham, NC, USA. Electronic address: corey001@mc.duke.edu.
authors.forename: G Ralph
authors.initials: GR
authors.lastname: Corey
mesh_terms: D000900:Anti-Bacterial Agents / Q000494:pharmacology* / Q000627:therapeutic use*; D002511:Cephalosporins / Q000494:pharmacology* / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy / Q000382:microbiology; D017277:Drug Approval; D006801:Humans; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects* / Q000302:isolation & purification; D008826:Microbial Sensitivity Tests; D011358:Product Surveillance, Postmarketing; D018461:Soft Tissue Infections / Q000188:drug therapy / Q000382:microbiology; D013203:Staphylococcal Infections / Q000188:drug therapy* / Q000382:microbiology*; D016896:Treatment Outcome; D014481:United States; D000097583:Ceftaroline
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D000097583:Ceftaroline
keywords: Ceftaroline; Clinical experience; MRSA; Post-market surveillance