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Summary of ceftaroline fosamil clinical trial studies and clinical safety.
Clin Infect Dis. 2012 Sep; 55 Suppl 3:S173-80.CI

Abstract

In October 2010, the new cephalosporin, ceftaroline fosamil, was approved by the US Food and Drug Administration for therapy of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs). The active metabolite, ceftaroline, demonstrates in vitro activity against typical bacterial pathogens most often associated with CABP or ABSSSIs, including resistant Gram-positive pathogens such as multidrug-resistant Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus. The efficacy and safety of ceftaroline fosamil was assessed in 2 large phase 3 programs of randomized, double-blind, clinical trials for CABP and ABSSSIs. For both indications, therapy with ceftaroline fosamil was observed to be noninferior to the comparator agents (ceftriaxone for CABP and vancomycin plus aztreonam for ABSSSIs) at both a standard test of cure assessment time (8-15 days after discontinuation of study drug) and an early assessment time point (day 3 or 4 of study). In the integrated analysis of the trials for CABP (FOCUS 1 and 2), clinical cure rates for the ceftaroline group were numerically higher than those for the ceftriaxone group (for the clinically evaluable population 84.3% vs 77.7%; difference: 6.6%; 95% confidence interval, 1.6%-11.8%). Among patients with CABP caused by S. pneumoniae, clinical cure rates were markedly higher in the ceftaroline treatment group than in the ceftriaxone treatment group (59 of 69 [85.5%] vs 48 of 70 [68.6%], respectively). For the ABSSSI studies (CANVAS 1 and 2), microbiologically evaluable (ME) success rates were similar between the treatment groups. Notably, the clinical cure rates in ME patients with methicillin-resistant S. aureus ABSSSIs were 142 of 152 (93.4%) and 115 of 122 (94.3%), for ceftaroline and vancomycin plus aztreonam, respectively, and did not differ from those achieved in infections due to methicillin-susceptible S. aureus (93.0%-94.5%). Ceftaroline fosamil was well tolerated, with a safety profile similar to the comparator agents used in these phase 3 trials.

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Authors+Show Affiliations

File TM
Infectious Disease Section, Northeast Ohio Medical University, Rootstown, USA. filet@summahealth.org
Wilcox MH
No affiliation info available
Stein GE
No affiliation info available

MeSH

Anti-Bacterial AgentsCephalosporinsClinical Trials as TopicHumansPneumonia, BacterialStaphylococcal Skin Infections

Pub Type(s)

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

Language

eng

PubMed ID

22903949

Citation

File, Thomas M., et al. "Summary of Ceftaroline Fosamil Clinical Trial Studies and Clinical Safety." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 55 Suppl 3, 2012, pp. S173-80.
File TM, Wilcox MH, Stein GE. Summary of ceftaroline fosamil clinical trial studies and clinical safety. Clin Infect Dis. 2012;55 Suppl 3:S173-80.
File, T. M., Wilcox, M. H., & Stein, G. E. (2012). Summary of ceftaroline fosamil clinical trial studies and clinical safety. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 55 Suppl 3, S173-80. https://doi.org/10.1093/cid/cis559
File TM, Wilcox MH, Stein GE. Summary of Ceftaroline Fosamil Clinical Trial Studies and Clinical Safety. Clin Infect Dis. 2012;55 Suppl 3:S173-80. PubMed PMID: 22903949.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Summary of ceftaroline fosamil clinical trial studies and clinical safety. AU - File,Thomas M,Jr AU - Wilcox,Mark H, AU - Stein,Gary E, PY - 2012/8/21/entrez PY - 2012/8/29/pubmed PY - 2012/11/2/medline SP - S173 EP - 80 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 55 Suppl 3 N2 - In October 2010, the new cephalosporin, ceftaroline fosamil, was approved by the US Food and Drug Administration for therapy of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs). The active metabolite, ceftaroline, demonstrates in vitro activity against typical bacterial pathogens most often associated with CABP or ABSSSIs, including resistant Gram-positive pathogens such as multidrug-resistant Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus. The efficacy and safety of ceftaroline fosamil was assessed in 2 large phase 3 programs of randomized, double-blind, clinical trials for CABP and ABSSSIs. For both indications, therapy with ceftaroline fosamil was observed to be noninferior to the comparator agents (ceftriaxone for CABP and vancomycin plus aztreonam for ABSSSIs) at both a standard test of cure assessment time (8-15 days after discontinuation of study drug) and an early assessment time point (day 3 or 4 of study). In the integrated analysis of the trials for CABP (FOCUS 1 and 2), clinical cure rates for the ceftaroline group were numerically higher than those for the ceftriaxone group (for the clinically evaluable population 84.3% vs 77.7%; difference: 6.6%; 95% confidence interval, 1.6%-11.8%). Among patients with CABP caused by S. pneumoniae, clinical cure rates were markedly higher in the ceftaroline treatment group than in the ceftriaxone treatment group (59 of 69 [85.5%] vs 48 of 70 [68.6%], respectively). For the ABSSSI studies (CANVAS 1 and 2), microbiologically evaluable (ME) success rates were similar between the treatment groups. Notably, the clinical cure rates in ME patients with methicillin-resistant S. aureus ABSSSIs were 142 of 152 (93.4%) and 115 of 122 (94.3%), for ceftaroline and vancomycin plus aztreonam, respectively, and did not differ from those achieved in infections due to methicillin-susceptible S. aureus (93.0%-94.5%). Ceftaroline fosamil was well tolerated, with a safety profile similar to the comparator agents used in these phase 3 trials. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/22903949/Summary_of_ceftaroline_fosamil_clinical_trial_studies_and_clinical_safety_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/cis559 DB - PRIME DP - Unbound Medicine ER -