Fidaxomicin Versus Vancomycin for Clostrium Difficile Infection

Fidaxomicin versus Vancomycin for Clostrium difficile Infection

Thomas J. Louie MD, Mark A. Miller MD, Kathleen M. Mullane DO, et. al.

NEJM 2011;364;422-31

October 2011

Background:

Clostridium difficile infections continue to rise, not just in hospitalized patients, but also in the community. Most of these infections are still cured by oral vancomycin and metronidazole, however recurrent infections are common. Newer agents are needed to treat and stop these recurrent infections, hence fidaxomicin, a new marolide antibiotic, was compared with vancomycin.

Objective:

To construct a noninferiority study to compare the safety and efficacy of fidaxomicin versus vancomycin in treating C. diff infections.

Study Type:

Prospective, multicenter, double-blind, randomized, parallel group trial

Study Duration:

This study was conducted from May 9, 2006 to August 21, 2008

Inclusion Criteria:

* Male or female > 16 years old who had C. diff infection (diarrhea and confirmed presence of C. diff toxin A or B within 48 hours of randomization)

* Females were required to use a reliable method of birth control with males and females agreeing to avoid conception during and for 4 weeks after treatment

* Patients who failed metronidazole course

Primary Outcome:

Rate of clinical cure defined as “resolution of diarrhea (<3 unformed stools for two consecutive days), with maintenance of resolution for the duration of therapy and no further requirement for therapy for C. difficile infection as of the second day after the end of the course of therapy”

Secondary Outcome:

Recurrence of C. diff infection 4 weeks after end of treatment course (reappearance of >3 unformed stools/24 hours; toxin presence; need for treatment) and global cure (resolution of diarrhea without recurrence)

Safety Outcome:

Assessed by physical exam, ERT, clinical lab testing (hematologic, biochemical, urinalysis), reports by patients of side effects...