Ceftaroline Shows Promise In the Treatment of CAP

SAN FRANCISCO — Ceftaroline demonstrated a higher clinical cure rate, compared with ceftriaxone in patients hospitalized with community-acquired pneumonia, according to combined results from two phase III studies.

A parenteral, broad-spectrum cephalosporin being developed by Forest Laboratories and AstraZeneca, ceftaroline “has a similar spectrum of activity as ceftriaxone, but it adds additional coverage against resistant gram-positive [organisms] that cause pneumonia in increasing frequency,” Dr. Paul Eckburg said in an interview during a poster session at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy.

The researchers enrolled 1,228 hospitalized patients with community-acquired pneumonia who required IV therapy; 614 received ceftaroline 600 mg every 12 hours and 614 received ceftriaxone (Rocephin) 1 gram every 24 hours. Each group was treated for 5–7 days. The mean age of patients was 61 years and 63% were male, Dr. Eckburg and his associates reported.

The primary objective of the two clinical trials was to determine noninferiority in the clinical cure rate with ceftaroline, compared with ceftriaxone (Rocephin) at 8–15 days after therapy. Of the 1,228 patients in the two trials, 908 met clinically evaluable criteria; they had clinical cure rates of 84.3% with ceftaroline and 77.7% with ceftriaxone.

“What surprised us was that the clinical cure rates were much higher in the ceftaroline arm than what we expected,” commented Dr. Eckburg, director of anti-infective development at Cerexa Inc., the wholly owned anti-infectives subsidiary of Forest Laboratories Inc. “We expected to see very similar cure rates.”

Among the 1,153 patients in the modified intent-to-treat efficacy group (limited to patients with class III and IV pneumonia), the overall clinical cure rates for ceftaroline and ceftriaxone were 82.6%and 76.6%.

Both drugs were well tolerated in the trials. Diarrhea was the most common adverse event (4.2% in ceftaroline users vs. 2.6% in ceftriaxone users), followed by headache (3.4% vs. 1.5%) and insomnia (3.1% vs. 2.3%).

“The bottom line is that we now have a new drug that shows similar efficacy to an older drug, ceftriaxone, but it offers additional coverage against emerging resistant pathogens,” Dr. Eckburg said.

The study was supported by Forest Laboratories.