NTIMICROBIALS AVAILABLE FOR treatment of complicated skin and skin structure infections (SSSIs) are generally efficacious, but antimicrobial resistance 1-7 and adverse effects limit their use. 1,8,9 Linezolid, an oxazolidinone, is the only drug approved for complicated SSSI caused by methicillinresistant Staphylococcus aureus (MRSA). Sporadic outbreaks of linezolidresistant strains of MRSA and enterococci, including those carrying a plasmid-borne cfr gene encoding the chloramphenicol/florfenicol resistance protein, have been reported. 10 Significant safety concerns with linezolid have emerged since it was approved in 2000 by the US Food and Drug Administration (FDA). 11 In 2010, the FDA issued a draft guidance for the development of systemic drugs to treat acute bacterial SSSIs (ABSSSIs) with recommendations for clinical response criteria and noninferiority trial design. 12,13 Given the time required to develop and obtain approval for a new chemical entity, trials demonstrating noninferiority to currently approved antimicrobials allow the development of new agents in advance of the selection of resistant pathogens in hospitals or in the community. Even within the same class of For editorial comment see p 609.
A single dose of oritavancin was noninferior to twice-daily vancomycin administered for 7 to 10 days for the treatment of acute bacterial skin and skin-structure infections caused by gram-positive pathogens. (Funded by the Medicines Company; SOLO I ClinicalTrials.gov number, NCT01252719.).
Ceftaroline fosamil achieved high clinical cure and microbiological success rates, was efficacious for cSSSIs caused by MRSA and other common cSSSI pathogens and was generally well tolerated. Ceftaroline fosamil has the potential to provide a monotherapy alternative for treatment of cSSSIs.
Ceftaroline fosamil demonstrated high clinical cure and microbiological response rates in hospitalized patients with CAP of PORT risk class III or IV. Ceftaroline fosamil was well tolerated, with a safety profile similar to that of ceftriaxone and consistent with the cephalosporin class. In this study, ceftaroline fosamil was an effective and well-tolerated treatment option for CAP.
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