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Merck reports data from Phase III trials of ZERBAXA in cUTI and cIAI

Merck has reported results from the pivotal Phase III clinical studies of ZERBAXA (ceftolozane/tazobactam) for Injection (1 g/0.5 g) in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), respectively.

The results will also appear in forthcoming print issues of the journals. Merck acquired ZERBAXA as a part of its purchase of Cubist Pharmaceuticals.

The publications report the results of two large, global, Phase 3 clinical studies of ZERBAXA – a study in patients with cUTI and a study in patients with cIAI. Both studies met the pre-specified primary endpoints, and results of the secondary analyses for the studies were consistent with and supportive of the primary outcomes.

"Physicians are in need of new treatment options to address complicated infections caused by serious Gram-negative bacteria. Publication of the ZERBAXA Phase 3 clinical study results in The Lancet and Clinical Infectious Diseases provides additional information to the infectious disease community and continues to support ZERBAXA as a new treatment for certain complicated urinary tract and complicated intra-abdominal infections," said René Russo, Pharm.D, BCPS, vice president, global medical affairs, Cubist Pharmaceuticals.

Approved in the U.S., ZERBAXA is indicated for use in combination with metronidazole in adult patients for the treatment of complicated intra-abdominal infections caused by the following Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus and Streptococcus salivarius.

ZERBAXA also is indicated in adult patients for the treatment of complicated urinary tract infections, including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

As described in The Lancet, the cUTI study was a multicenter, double-blind trial in which 1,083 hospitalized adult patients with cUTI, including pyelonephritis, were randomized to receive either intravenous (I.V.) ZERBAXA (1.5 g q8h) or high-dose I.V. levofloxacin (750 mg qd) for seven days.

In this study, treatment with ZERBAXA was shown to be effective in patients with cUTI and pyelonephritis, including a majority of infections caused by levofloxacin-resistant pathogens. The comparator levofloxacin is a common treatment option for cUTI and pyelonephritis, and is included in international clinical practice guidelines for cUTI.

ZERBAXA met the study’s primary endpoint of statistical non-inferiority compared to levofloxacin (10% non-inferiority margin).

The primary endpoint was a composite of microbiological eradication and clinical cure rate (composite cure rate) at 5-9 days after the end of therapy (the test of cure visit). The 95% confidence interval around the treatment difference had lower and upper bounds of 2.3% and 14.6%, respectively.

"These clinical trial results are important because ceftolozane/tazobactam is a new treatment option for patients facing complicated urinary tract infections caused by certain susceptible Gram-negative bacteria," said The Lancet publication lead author Florian M. Wagenlehner, M.D., Ph.D., Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University, and faculty member of the German Center for Infection Research, Gießen-Marburg-Langen site.

"Gram-negative bacteria are prevalent globally and know no geographic boundaries. With the increasing challenge of antibiotic resistance, the treatment of complicated urinary tract infections has become more difficult to manage, and new therapies are needed."