ARTICLE | Clinical News
Vicuron enrolls dalbavancin SSTI Phase III
May 11, 2004 7:00 AM UTC
Vicuron (MICU; NMerc:MICU) completed enrollment of about 1,500 patients in three Phase III trials of its dalbavancin second generation glycopeptide antibiotic to treat skin and skin structure infections (SSSIs). Data are expected in the second half, and MICU plans to submit an NDA by year end.
One trial is a 14-day, double-blind study comparing intravenous dalbavancin to intravenous linezolid to treat complicated SSSIs. The second double-blind trial is comparing intravenous dalbavancin to intravenous cefazolin followed by oral cephalexin to treat uncomplicated SSSIs. The primary endpoint in both studies is overall clinical and microbiological response. ...