Dr. Thomas M. File of Northeastern Ohio Universities Colleges of Medicine and Pharmacy, Rootstown, and colleagues note that ceftaroline fosamil is a new broad-spectrum cephalosporin prodrug.
In fact, last month (October), the US Food and Drug Administration approved ceftaroline (Teflaro; Forest Laboratories) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection.
For the current study, the authors integrated data from two randomized, double-blind, multicenter trials known as FOCUS 1 and 2, comparing intravenous ceftaroline 600 mg every 12 hours to ceftriaxone 1 g every 24 hours for 5-7 days in patients hospitalized (but not admitted to the ICU) with community-acquired pneumonia.
In the integrated analysis, 614 patients received ceftaroline and 614 received ceftriaxone. Among patients that could be evaluated clinically, clinical cure rates were 84.3% with ceftaroline compared to 77.7% with ceftriaxone. On intent-to-treat analysis, corresponding rates were 82.6% versus 76.6%, according to the report.
As for safety, “The incidences of treatment-emergent adverse events were similar between treatment groups,” the authors report. Among ceftaroline-treated patients the most common side effects were diarrhea, headache, and insomnia while diarrhea, hypertension, and hypokalemia were most frequent in ceftriaxone-treated patients.
Serious adverse events deemed related to the study drug occurred in two patients given ceftaroline and three treated with ceftriaxone.
“In conclusion,” Dr. File and colleagues write, “the integrated analysis of the FOCUS trials demonstrates that ceftaroline is efficacious and well tolerated for treatment of CAP (community-acquired pneumonia).”
Integrated Analysis of FOCUS 1 and FOCUS 2: Randomized, Doubled‐Blinded, Multicenter Phase 3 Trials of the Efficacy and Safety of Ceftaroline Fosamil versus Ceftriaxone in Patients with Community‐Acquired Pneumonia
Clin Infect Dis 2010;51.