In this multicentre, double-blind, randomised, non-inferiority trial, we enrolled patients from 45 sites in Europe and 41 sites in the USA and Canada between April 19, 2007, and Dec 11, 2009. Eligible patients were aged 16 years or older with acute, toxin-positive
Of 535 patients enrolled, 270 were assigned fidaxomicin and 265 vancomycin. After 26 patients were excluded, 509 were included in the modified intention-to-treat (mITT) population. 198 (91路7%) of 216 patients in the per-protocol population given fidaxomicin achieved clinical cure, compared with 213 (90路6%) of 235 given vancomycin, meeting the criterion for non-inferiority (one-sided 97路5%CI 鈭?路3%). Non-inferiority was also shown for clinical cure in the mITT population, with 221 (87路7%) of 252 patients given fidaxomicin and 223 (86路8%) of 257 given vancomycin cured (one-sided 97路5%CI 鈭?路9%). In most subgroup analyses of the primary endpoint in the mITT population, outcomes in the two treatment groups did not differ significantly; although patients receiving concomitant antibiotics for other infections had a higher cure rate with fidaxomicin (46 [90路2%] of 51) than with vancomycin (33 [73路3%] of 45; p=0路031). Occurrence of treatment-emergent adverse events did not differ between groups. 20 (7路6%) of 264 patients given at least one dose of fidaxomicin and 17 (6路5%) of 260 given vancomycin died.
Fidaxomicin could be an alternative treatment for infection with
Optimer Pharmaceuticals.