Advancis’ pediatric pivotal program is designed as a 500-patient, investigator-blind, non-inferiority phase III trial for a ‘sprinkle’ formulation of amoxicillin Pulsys for the treatment of pediatric patients with acute pharyngitis/tonsillitis.
In the trial, Advancis is comparing amoxicillin Pulsys once-daily sprinkle dosage for a period of seven days to 10mg/kg of penicillin VK dosed four times daily for 10 days. The primary endpoint is bacterial eradication, as measured by throat cultures both before and after treatment.
Over the coming weeks, pediatric patients will complete their treatment and follow-up visits, and Advancis and its clinical research organization, Quintiles Inc, will collect and analyze the clinical data. Trial enrollment began on January 5, 2005, and the company expects to publicly report top-line results for the trial in July.