Ceftazidime/avibactam meets in cIAI trials

AstraZeneca plc (LSE:AZN; NYSE:AZN) and Actavis plc (NYSE:ACT) said IV ceftazidime/ avibactam ( CAZ-104) plus metronidazole met the EMA- and FDA-defined primary endpoints of non-inferiority to meropenem in pooled data from the identical Phase III RECLAIM-1 and RECLAIM-2 trials to treat complicated intra-abdominal infections (cIAIs). The EMA-defined co-primary endpoints were non-inferiority in improving the clinical cure rate at test-of-cure visit in both the modified-intent-to-treat (MITT) and clinically evaluable patient populations. The FDA-defined primary endpoint was non-inferiority in improving clinical cure rate at the test-of-cure visit in the microbiological MITT population.

The MITT population was defined as patients who received at least one dose of ceftazidime/avibactam, and the microbiological MITT population comprised MITT patients who had a detectable bacterial infection at baseline. The clinically evaluable population included all patients who completed treatment per protocol. The trials enrolled a combined 1,066 patients. ...