Fidaxomicin effective for Clostridium difficile infection

January 01, 0001

Fidaxomicin effective for Clostridium difficile infection

This was a phase 3 clinical trial by Canadian and US authors comparing the efficacy and safety of fidaxomicin with those of vancomycin in treating C. difficile infection. Adults with acute symptoms of C. difficile infection and a positive result on a stool toxin test were eligible for study entry. They were randomly assigned to receive fidaxomicin (200 mg twice daily) or vancomycin (125 mg four times daily) orally for 10 days.

They found: "A total of 629 patients were enrolled, of whom 548 (87.1%) could be evaluated for the per-protocol analysis. The rates of clinical cure with fidaxomicin were noninferior to those with vancomycin in both the modified intention-to-treat analysis (88.2% with fidaxomicin and 85.8% with vancomycin) and the per-protocol analysis (92.1% and 89.8%, respectively). Significantly fewer patients in the fidaxomicin group than in the vancomycin group had a recurrence of the infection, in both the modified intention-to-treat analysis (15.4% vs. 25.3%) and the per-protocol analysis (13.3% vs. 24.0%). The lower rate of recurrence was seen in patients with non-North American Pulsed Field type 1 strains. The adverse-event profile was similar for the two therapies."

The authors concluded: "The rates of clinical cure after treatment with fidaxomicin were noninferior to those after treatment with vancomycin. Fidaxomicin was associated with a significantly lower rate of recurrence of C. difficile infection associated with non-North American Pulsed Field type 1 strains."

Cost of therapy will be a factor to consider.


For the full abstract, click here.

NEJM 364:422-431, 3 February 2011
© 2011 to the Massachusetts Medical Society
Fidaxomicin versus Vancomycin for Clostridium difficile Infection. Thomas J. Louie, Mark A. Miller, Kathleen M. Mullane, et al. Correspondence to Dr. Louie: [email protected]

Category: D. Digestive. Keywords: Clostridium difficile, fidaxomicin, vancomycin, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 15 February 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.