FEBRUARY 3, 2011 | Thomas J. Louie, M.D., Mark A. Miller, M.D., Kathleen M. Mullane, D.O., Karl Weiss, M.D., Arnold Lentnek, M.D., Yoav Golan, M.D., Sherwood Gorbach, M.D., Pamela Sears, Ph.D., and Youe-Kong Shue, Ph.D., for the OPT-80-003 Clinical Study Group
This phase 3 clinical trial compared the efficacy and safety of fidaxomicin and vancomycin in treating Clostridium difficile infection (CDI). Adults with acute CDI and a positive stool toxin test were randomly assigned to receive fidaxomicin (200 mg twice daily) or vancomycin (125 mg four times daily) for 10 days. The primary endpoint was clinical cure, defined as resolution of symptoms and no need for further therapy by the second day after the end of treatment. Secondary endpoints included recurrence of CDI and global cure. A total of 629 patients were enrolled, with 548 evaluated for the per-protocol analysis. Fidaxomicin was noninferior to vancomycin in terms of clinical cure rates, with a significantly lower rate of recurrence, particularly in patients with non-NAP1/Bj/027 strains. The adverse event profile was similar for both treatments. The study concluded that fidaxomicin is a safe and effective alternative to vancomycin for treating CDI, with a lower rate of recurrence and improved global cure rates.This phase 3 clinical trial compared the efficacy and safety of fidaxomicin and vancomycin in treating Clostridium difficile infection (CDI). Adults with acute CDI and a positive stool toxin test were randomly assigned to receive fidaxomicin (200 mg twice daily) or vancomycin (125 mg four times daily) for 10 days. The primary endpoint was clinical cure, defined as resolution of symptoms and no need for further therapy by the second day after the end of treatment. Secondary endpoints included recurrence of CDI and global cure. A total of 629 patients were enrolled, with 548 evaluated for the per-protocol analysis. Fidaxomicin was noninferior to vancomycin in terms of clinical cure rates, with a significantly lower rate of recurrence, particularly in patients with non-NAP1/Bj/027 strains. The adverse event profile was similar for both treatments. The study concluded that fidaxomicin is a safe and effective alternative to vancomycin for treating CDI, with a lower rate of recurrence and improved global cure rates.