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Fidaxomicin an alternative to vancomycin for C. difficile

Clinical Question:
Is fidaxomicin more effective than vancomycin for treating Clostridium difficile infection?

Bottom Line:
Fidaxomicin is similarly effective to vancomycin for treating C. difficile infection. It reduces the risk of recurrence, although not for the newer more virulent strain. It remains to be seen whether its increased cost is balanced by faster hospital discharge. (LOE = 1b)

Louie TJ, Miller MA, Mullane KM, et al, for the OPT-80-003 Clinical Study Group. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011;364(5):422-431.  [PMID:21288078]

Study Design:
Randomized controlled trial (double-blinded)



Inpatient (any location)

C. difficile is an increasingly common nosocomial infection, and a new strain (NAP1/BI/027) is associated with more severe infections and worse outcomes. Fidaxomicin is a macrocyclic, bacteriocidal, nonsystemic antibiotic that provides an alternative to vancomycin. This is a multicenter trial that randomized adults with C. difficile infection to either 200 mg fidaxomicin twice daily or vancomycin 125 mg every 6 hours, both for 10 days. Allocation was concealed, and groups (including both inpatients and outpatients) were balanced at the start of the study. The analyses were by modified intention to treat (at least 1 dose of study medication, n = 596) or per protocol (n = 548). Patients who had a clinical cure were monitored for up to 40 days to look for evidence of recurrence. The clinical cure rate (3 or fewer unformed stools for 2 continuous days) was similar between the vancomycin and fidaxomicin groups for both modified intention-to-treat and per protocol analyses. The recurrence rate was somewhat lower with fidaxomicin (15.4% vs 25.3%; P = .005; number needed to treat = 10). However, the recurrence rate was similar between groups for the new, more virulent NAP1/BI/027 strain (24.4% vs 23.6%). Although the duration of symptoms was shorter with fidaxomicin, the difference was not statistically significant. Adverse events were similar between groups.


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