Ceftaroline: clinical and microbiology experience with focus on methicillin-resistant Staphylococcus aureus after regulatory approval in the USA

Diagn Microbiol Infect Dis. 2015 Mar;81(3):183-8. doi: 10.1016/j.diagmicrobio.2014.11.016. Epub 2014 Dec 3.

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.

Keywords: Ceftaroline; Clinical experience; MRSA; Post-market surveillance.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Anti-Bacterial Agents / pharmacology*
  • Anti-Bacterial Agents / therapeutic use*
  • Ceftaroline
  • Cephalosporins / pharmacology*
  • Cephalosporins / therapeutic use*
  • Community-Acquired Infections / drug therapy
  • Community-Acquired Infections / microbiology
  • Drug Approval
  • Humans
  • Methicillin-Resistant Staphylococcus aureus / drug effects*
  • Methicillin-Resistant Staphylococcus aureus / isolation & purification
  • Microbial Sensitivity Tests
  • Product Surveillance, Postmarketing
  • Soft Tissue Infections / drug therapy
  • Soft Tissue Infections / microbiology
  • Staphylococcal Infections / drug therapy*
  • Staphylococcal Infections / microbiology*
  • Treatment Outcome
  • United States

Substances

  • Anti-Bacterial Agents
  • Cephalosporins