Cethromycin will be evaluated using a 300mg once-daily dosing regimen over a seven-day course of therapy. The clinical cure rate at the ‘test-of-cure’ visit will be the primary endpoint for the trial.
Approximately 250 patients are planned for enrollment in each arm of the study. Enrollment will occur in sites in the Northern and Southern Hemispheres to capture the CAP seasons in each geography and enable year-round enrollment.
“We are very pleased to get our pivotal trials underway,” said Dr Michael Flavin, chairman and CEO of Advanced Life Sciences. “The initiation of enrollment and first patient dosing in our phase III pivotal trial is a significant achievement for Advanced Life Sciences.”