The Department of Health and Health Protection Agency (Public Health England) have issued new best practice guidance recommending fidaxomicin, a first-in-class antibiotic for Clostridium difficile infection (CDI) for the treatment of CDI in adults with CDI recurrence and/or with severe cases of the infection who are considered at high risk for recurrence.
In clinical trials, fidaxomicin demonstrated a similar efficacy and safety profile to the current mainstay of therapy, vancomycin (primary endpoint), but more than halved the rate of recurrence in patients with CDI compared to vancomycin (planned secondary endpoint, 12.7% versus 26.9%, p=0.0002). Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current treatment and has been identified as the most important problem in CDI treatment.
Having launched in the UK in June 2012, there are inconsistencies from the various national bodies around recommended patient types in which to use fidaxomicin.