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Positive Results Reported for Ceftolozane/Tazobactam in Intra-Abdominal Infections
Phase III trial shows noninferiority versus meropenem (December 16)
Positive results have been reported from a phase III clinical trial of the antibiotic candidate ceftolozane/tazobactam (Cubist Pharmaceuticals) in patients with complicated intra-abdominal infections (cIAIs).
The treatment, in combination with metronidazole, met the FDA’s defined primary endpoint of statistical non-inferiority compared with meropenem. The primary endpoint was a clinical cure rate 26 to 30 days after the initiation of therapy (the Test of Cure visit).
The treatment-emergent adverse event rates were 44.0% for ceftolozane/tazobactam in combination with metronidazole, and 42.7% for meropenem. The most commonly reported adverse events for ceftolozane/tazobactam in combination with metronidazole were nausea (7.9%), diarrhea (6.2%), fever (5.2%), insomnia (3.5%), and vomiting (3.3%).
The most common Gram-negative pathogens observed in the trial included Escherichia coli, Klebsiella pneumonia, and Pseudomonas aeruginosa.
The new trial results follow positive data reported last month from a phase III study of ceftolozane/tazobactam compared with levofloxacin in patients with complicated urinary tract infections (cUTIs).
Ceftolozane/tazobactam, an antibiotic candidate being developed to treat certain Gram-negative infections, consists of ceftolozane, a new cephalosporin that has demonstrated more potent in vitro activity against P. aeruginosa compared with that of the currently available cephalosporins, with tazobactam, a well-established beta-lactamase inhibitor. The addition of tazobactam broadens coverage to include most extended-spectrum beta-lactamase (ESBL)-producing E. coli, K. pneumoniae, and other Enterobacteriaceae. Ceftolozane/tazobactam is being developed for the potential treatment of cUTIs and cIAIs.
Source: Cubist Pharmaceuticals; December 16, 2013.