BioCentury
ARTICLE | Clinical News

Ceftolozane/tazobactam: Additional Phase III data

September 1, 2014 7:00 AM UTC

Additional pooled data from 993 patients with cIAIs in a pair of identical, double-blind, double-dummy, international Phase III trials showed that 1.5 g IV ceftolozane/tazobactam every 8 hours plus 0.5 g IV metronidazole for 4-14 days led to a clinical cure rate in the MITT population at the TOC visit 26-30 days after the start of therapy, the FDA-defined primary endpoint, of 83% vs. 87.3% for 1 g IV meropenem every 8 hours for 4-14 days. Ceftolozane/tazobactam plus metronidazole led to a clinical cure rate in the clinically evaluable population at the TOC visit, the EMA-defined primary endpoint, of 94.1% vs. 94% for meropenem. Data were presented at the European Congress of Clinical Microbiology and Infectious Diseases in Barcelona. Cubist previously reported that ceftolozane/tazobactam plus metronidazole met the FDA- and EMA-defined primary endpoints of non-inferiority to meropenem (see BioCentury, Dec. 23, 2013). ...