ARTICLE | Clinical News

Fidaxomicin: Additional Phase III data

September 20, 2010 7:00 AM UTC

Pooled data from a pair of double-blind Phase III trials in 1,164 patients showed that in patients with a recurrent episode of CDI within 3 months of entering the trials (n=128), fidaxomicin significantly reduced the proportion of patients who experienced another recurrence vs. Vancocin vancomycin (19.7% vs. 35.5%, p=0.045). In 336 evaluable patients who received concomitant antibiotics, fidaxomicin had a significantly lower CDI recurrence rate (17% vs. 28%, p=0.039) and a significantly higher global cure rate vs. Vancocin (73% vs. 60%, p=0.013). Fidaxomicin also led to a significantly lower CDI recurrence rate in 663 evaluable patients who received no concomitant antibiotics vs. Vancocin (11.5% vs. 23%, p<0.001). Data were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Boston. ...