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Ceftaroline well-tolerated, comparable to ceftriaxone in community-acquired pneumonia
File T. Clin Infect Dis. 2010;51:1395-1405.
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In an integrated analysis of the FOCUS 1 and FOCUS 2 studies, data suggest that ceftaroline, the active form of ceftaroline fosamil, is effective, well tolerated and has a safety profile similar to that of ceftriaxone for the treatment of community-acquired pneumonia.
Thomas M. File, MD, MS, of Northeastern Ohio Universities Colleges of Medicine and Pharmacy, and member of the Infectious Disease News Editorial Board, and colleagues from the Ceftaroline Community Acquired Pneumonia Trial versus Ceftriaxone in Hospitalized Patients (FOCUS) group, conducted two randomized, double-blind, multicenter trials (FOCUS 1 and FOCUS 2) to evaluate the safety and efficacy of ceftaroline vs. ceftriaxone.
"Ceftaroline achieved numerically higher cure rates than ceftriaxone," File told Infectious Disease News. "The better response may in part be due to the greater in vitro activity of ceftaroline against the most significant pathogen of community-acquired pneumonia — S. pneumoniae."
The primary objective was to determine noninferiority in clinical cure rates of ceftaroline compared with ceftriaxone in the clinically evaluable and modified intent-to-treat efficacy populations at the test-of-cure visit.
Patients were randomly assigned to 600 mg ceftaroline every 12 hours or 1 g ceftriaxone every 24 hours for 5 to 7 days. Patients in FOCUS 1 received 2 doses of oral clarithromycin 500 mg every 12 hours on the first day.
Clinical cure rates in the clinically evaluable population of FOCUS 1 were 86.6% for ceftaroline compared with 78.2% for ceftriaxone (difference, 8.4%; 95%CI, 1.4%-15.4%). In FOCUS 2, clinical cure rates were 82.1% for ceftaroline vs. 77.2% for ceftriaxone (difference, 4.9%; 95% CI, -2.5% to 12.5%), the researchers found.
In the integrated analysis, 614 patients received ceftaroline and 614 received ceftriaxone. Of the clinically evaluable patients treated with ceftaroline, 84.3% achieved clinical cure, compared with 77.7% of ceftriaxone-treated patients (difference, 6.7%; 95% CI, 1.6%-11.8%), the researchers reported.
In addition, clinical cure rates in the modified intent-to-treat efficacy population were 82.6% for ceftaroline vs. 76.6% for ceftriaxone (difference, 6.0%; 95% CI, 1.4%-10.7%), the researchers added, and both drugs were well-tolerated.
“In each study, ceftaroline achieved noninferiority to ceftriaxone in the coprimary populations. Of note, the differences in success rates in the clinically evaluable, microbiologically evaluable, and microbiological modified intent-to-treat efficacy populations in FOCUS 1 were statistically significant in favor of ceftaroline,” the researchers wrote. – by Ashley DeNyse
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