Ceftaroline Fosamil For Treatment Of Hospitalized Patients

Global increase in incidence of infections with multi drug resistant organisms has highlighted the need of development of new antibiotics.  Generally, the first line treatment for complicated skin and skin-structure infections (cSSSIs) caused by   MRSA includes vancomycin, linezolid, or daptomycin; and for outpatients oral clindamycin, doxycycline, or sulfamethoxazole-trimethoprim. The effectiveness of these drugs can be restricted by a narrow spectrum of activity, emergence of resistance, monitoring of serum concentration, and adverse effects.

Ceftaroline fosamil (Ceftaroline) is a novel, broad spectrum cephalosporin which exhibits bactericidal activity against gram-positive organisms (including MRSA), vancomycin-intermediate S. aureus and macrolide-resistant S. pyogenes, as well as ram-negative pathogens, including non–extended-spectrum β-lactamase (ESBL)–producing Klebsiella pneumonia and Escherichia coli. Ceftaroline was being under investigation for treatment of hospitalized patients with complicated skin and skin-structure infections (cSSSIs).

On October 29, 2010, the FDA announced the approval of ceftaroline (Teflaro) for treatment of acute bacterial skin and soft-tissue infections (BSSTIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA) in adults aged > 18.

A Phase 3, Multicenter, Randomized, Double-Blind Studies were conducted to evaluate the safety and efficacy of Ceftaroline versus Vancomycin plus Aztreonam in (cSSSIs). Data from 11300 patients in this analysis demonstrated that ceftaroline monotherapy was generally safe and well tolerated, consistent with the safety profile of the cephalosporin class. The incidence of treatment-emergent adverse events was similar between treatment groups. No cardiac, hepatic, or renal toxicity signal was identified. In conclusion, ceftaroline administered intravenously to adults at a dosage of 600 mg every 12 h for 5–14 days was efficacious and well tolerated for the treatment of cSSSI.

In view of these analyses, ceftaroline has the potential to provide a monotherapy alternative for the treatment of cSSSI.

References:

 Forest Laboratories (2010-10-29). “Forest Announces FDA Approval of Teflaro(TM) (ceftaroline fosamil) for the Treatment of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infection”. Press release. http://www.frx.com/news/PressRelease.aspx?ID=1489398.

Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated Analysis of CANVAS 1 and 2: Phase 3, Multicenter, Randomized, Double-Blind Studies to Evaluate the Safety and Efficacy of Ceftaroline versus Vancomycin plus Aztreonam in Complicated Skin and Skin-Structure Infection. Clin Infect Dis. 2010 Sep 15; 51: 641-50.