Ceftaroline Noninferior to Vancomycin/Aztreonam

WASHINGTON — The investigational antibiotic ceftaroline was found to be effective against a range of gram-positive and gram-negative organisms that can cause complicated skin and skin structure infections, according to data from a phase III noninferiority study of more than 600 patients.

Clinical cure rates (8–15 days after the end of therapy) were similar for patients who received at least one dose of ceftaroline or vancomycin/aztreonam (the modified intent-to-treat population)—87% for those on ceftaroline and 86% for those on vancomycin-aztreonam, according to data from the CANVAS-1 study presented as a poster at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

“Ceftaroline monotherapy was as effective and well tolerated as vancomycin plus aztreonam combination therapy in treating patients with complicated skin and skin structure infections due to both gram-positive and gram-negative pathogens,” reported Dr. Ralph Corey of Duke University, Durham, N.C., and his coinvestigators.

The study was supported by Forrest Laboratories Inc., which is developing ceftaroline. Two of Dr. Corey's coinvestigators are employed by Cerexa Inc., wholly owned subsidiary of Forrest. Dr. Corey disclosed receiving research funding and serving as an adviser to Cerexa.

The double-blind study randomized patients to either 600 mg intravenous ceftaroline every 12 hours for 5–14 days or 1 g intravenous vancomycin plus 1 g intravenous aztreonam (Azactam) every 12 hours for 5–14 days. Aztreonam was discontinued if gram-negative pathogens were not identified or suspected.

At enrollment, 353 patients were randomized to receive ceftaroline and 349 were randomized to receive vancomycin/aztreonam. The modified intention-to-treat population included all patients who had received any study drug—351 patients in the ceftaroline group and 347 patients in the vancomycin/aztreonam group.

Almost a quarter of the patients in each group—21% in the ceftaroline group and 25% in the vancomycin/aztreonam group—had polymicrobial infection. The most common infection type was deep, extensive cellulitis (35% in both groups), followed by major abscess (28% of the ceftaroline group and 29% of the vancomycin/aztreonam group).

There were 471 patients—244 in the ceftaroline group and 227 in the vancomycin/aztreonam group—who were microbiologically evaluable. Microbiologic eradication was achieved in 92% of patients on ceftaroline and 93% of patients on vancomycin/aztreonam.

Staphylococcus aureus was the most commonly isolated organism. But ceftaroline was effective against a range of gram-positive and gram-negative organisms. (See box.)

Most adverse events were mild—72% for both groups. The most common adverse event in the ceftaroline group was nausea (5.7%), followed by headache (5.1%). The most common adverse event in the vancomycin/aztreonam group was pruritus (8.4%).

“Ceftaroline has the potential to provide a monotherapy option for the treatment of complicated skin and skin structure infections,” the investigators wrote.

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WASHINGTON — The investigational antibiotic ceftaroline was found to be effective against a range of gram-positive and gram-negative organisms that can cause complicated skin and skin structure infections, according to data from a phase III noninferiority study of more than 600 patients.

Clinical cure rates (8–15 days after the end of therapy) were similar for patients who received at least one dose of ceftaroline or vancomycin/aztreonam (the modified intent-to-treat population)—87% for those on ceftaroline and 86% for those on vancomycin-aztreonam, according to data from the CANVAS-1 study presented as a poster at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

“Ceftaroline monotherapy was as effective and well tolerated as vancomycin plus aztreonam combination therapy in treating patients with complicated skin and skin structure infections due to both gram-positive and gram-negative pathogens,” reported Dr. Ralph Corey of Duke University, Durham, N.C., and his coinvestigators.

The study was supported by Forrest Laboratories Inc., which is developing ceftaroline. Two of Dr. Corey's coinvestigators are employed by Cerexa Inc., wholly owned subsidiary of Forrest. Dr. Corey disclosed receiving research funding and serving as an adviser to Cerexa.

The double-blind study randomized patients to either 600 mg intravenous ceftaroline every 12 hours for 5–14 days or 1 g intravenous vancomycin plus 1 g intravenous aztreonam (Azactam) every 12 hours for 5–14 days. Aztreonam was discontinued if gram-negative pathogens were not identified or suspected.

At enrollment, 353 patients were randomized to receive ceftaroline and 349 were randomized to receive vancomycin/aztreonam. The modified intention-to-treat population included all patients who had received any study drug—351 patients in the ceftaroline group and 347 patients in the vancomycin/aztreonam group.

Almost a quarter of the patients in each group—21% in the ceftaroline group and 25% in the vancomycin/aztreonam group—had polymicrobial infection. The most common infection type was deep, extensive cellulitis (35% in both groups), followed by major abscess (28% of the ceftaroline group and 29% of the vancomycin/aztreonam group).

There were 471 patients—244 in the ceftaroline group and 227 in the vancomycin/aztreonam group—who were microbiologically evaluable. Microbiologic eradication was achieved in 92% of patients on ceftaroline and 93% of patients on vancomycin/aztreonam.

Staphylococcus aureus was the most commonly isolated organism. But ceftaroline was effective against a range of gram-positive and gram-negative organisms. (See box.)

Most adverse events were mild—72% for both groups. The most common adverse event in the ceftaroline group was nausea (5.7%), followed by headache (5.1%). The most common adverse event in the vancomycin/aztreonam group was pruritus (8.4%).

“Ceftaroline has the potential to provide a monotherapy option for the treatment of complicated skin and skin structure infections,” the investigators wrote.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — The investigational antibiotic ceftaroline was found to be effective against a range of gram-positive and gram-negative organisms that can cause complicated skin and skin structure infections, according to data from a phase III noninferiority study of more than 600 patients.

Clinical cure rates (8–15 days after the end of therapy) were similar for patients who received at least one dose of ceftaroline or vancomycin/aztreonam (the modified intent-to-treat population)—87% for those on ceftaroline and 86% for those on vancomycin-aztreonam, according to data from the CANVAS-1 study presented as a poster at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

“Ceftaroline monotherapy was as effective and well tolerated as vancomycin plus aztreonam combination therapy in treating patients with complicated skin and skin structure infections due to both gram-positive and gram-negative pathogens,” reported Dr. Ralph Corey of Duke University, Durham, N.C., and his coinvestigators.

The study was supported by Forrest Laboratories Inc., which is developing ceftaroline. Two of Dr. Corey's coinvestigators are employed by Cerexa Inc., wholly owned subsidiary of Forrest. Dr. Corey disclosed receiving research funding and serving as an adviser to Cerexa.

The double-blind study randomized patients to either 600 mg intravenous ceftaroline every 12 hours for 5–14 days or 1 g intravenous vancomycin plus 1 g intravenous aztreonam (Azactam) every 12 hours for 5–14 days. Aztreonam was discontinued if gram-negative pathogens were not identified or suspected.

At enrollment, 353 patients were randomized to receive ceftaroline and 349 were randomized to receive vancomycin/aztreonam. The modified intention-to-treat population included all patients who had received any study drug—351 patients in the ceftaroline group and 347 patients in the vancomycin/aztreonam group.

Almost a quarter of the patients in each group—21% in the ceftaroline group and 25% in the vancomycin/aztreonam group—had polymicrobial infection. The most common infection type was deep, extensive cellulitis (35% in both groups), followed by major abscess (28% of the ceftaroline group and 29% of the vancomycin/aztreonam group).

There were 471 patients—244 in the ceftaroline group and 227 in the vancomycin/aztreonam group—who were microbiologically evaluable. Microbiologic eradication was achieved in 92% of patients on ceftaroline and 93% of patients on vancomycin/aztreonam.

Staphylococcus aureus was the most commonly isolated organism. But ceftaroline was effective against a range of gram-positive and gram-negative organisms. (See box.)

Most adverse events were mild—72% for both groups. The most common adverse event in the ceftaroline group was nausea (5.7%), followed by headache (5.1%). The most common adverse event in the vancomycin/aztreonam group was pruritus (8.4%).

“Ceftaroline has the potential to provide a monotherapy option for the treatment of complicated skin and skin structure infections,” the investigators wrote.

ELSEVIER GLOBAL MEDICAL NEWS