In the study, patients who took 400 mg once daily of AVELOX intravenous (I.V.) followed by oral monotherapy achieved similar clinical cure rates (80 percent) at the test-of-cure visit (the primary efficacy endpoint) as patients who took a standard regimen of I.V. piperacillin-tazobactam followed by oral amoxicillin-clavulanate (78 percent).
Importantly, AVELOX demonstrated a significantly higher cure rate of 82 percent compared to 55 percent for the combination therapy among patients who acquired their cIAI in a hospital setting (including both mild-to-moderate and more severe hospital-acquired infections). Hospital-acquired infections are often caused by more resistant bacteria than community-acquired infections. Clinical cure rates for patients with community-acquired infections were similar between the two treatment groups.
The incidence of adverse events in the study due to any cause was similar for the two treatment groups, with the majority being mild or moderate in nature. The most common adverse events were nausea, hypokalemia, abdominal pain and constipation. The incidence of drug-related serious adverse events or premature discontinuation due to adverse events was similar for the two treatment groups.
"The results of this study are