Positive top-line Ph III results with ceftolozane/tazobactam in cUTI
US biopharma company Cubist Pharmaceuticals (Nasdaq: CBST) has revealed positive top-line results from its pivotal Phase III clinical trial of its antibiotic candidate ceftolozane/tazobactam in complicated urinary tract infections (cUTI).
Ceftolozane/tazobactam met its primary endpoint of statistical non-inferiority compared to levofloxacin (10% non-inferiority margin). The primary endpoint is a composite of microbiological eradication and clinical cure rate (composite cure rate) at five to nine days after 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, favoring ceftolozane/tazobactam. Results of the secondary analyses were consistent with and supportive of the primary outcome.
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