Clostridium difficile infection: fidaxomicin

NICE advice [ESNM1] Published date:

Key points from the evidence

Fidaxomicin (Dificlir) is the first in a new class of macrocylic antibiotics and has recently been licensed by the European Medicines Agency (EMA) for the treatment of Clostridium difficile infection (CDI). Current Health Protection Agency (HPA) guidance recommends metronidazole as first-line therapy in mild to moderate CDI, but vancomycin in severe cases. Fidaxomicin has not been compared to metronidazole in clinical trials.

Evidence from two double-blind, randomised controlled trials indicates it is non-inferior to vancomycin in curing patients with mild to severe CDI. Its side-effect profile appears similar to that of oral vancomycin and it may have advantages in reducing the rate of recurrence.

When considering the use of fidaxomicin, local decision makers should take into account the potential benefits alongside the medical need, the risks of treatment, and the relatively high cost of fidaxomicin in comparison with other treatments for CDI.

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