Cubist announced results from a Phase 3 trial of ceftolozane/tazobactam for the treatment of serious infections including complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). Ceftolozane is a cephalosporin antibiotic; tazobactam is a β-lactamase inhibitor.
In the cUTI trial, ceftolozane/tazobactam met its primary endpoint of statistical non-inferiority compared to levofloxacin. 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 (TOC) visit. The composite cure rates at TOC in the Microbiological Modified Intent-to-Treat (mMITT) and Per Protocol (PP) populations were 76.9% vs. 68.4% and 83.3% vs. 75.4%, respectively.
Ceftolozane/tazobactam in combination with metronidazole, also met the primary endpoints of statistical non-inferiority compared to meropenem in the cIAI trial. The primary endpoint was a clinical cure rate 26–30 days after the initiation of therapy, the TOC visit. The primary analysis was conducted in the MITT population where the overall clinical cure rate was 83.0% for ceftolozane/tazobactam in combination with metronidazole vs. 87.3% for meropenem. Statistical non-inferiority was defined at a pre-specified 10% non-inferiority margin.
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