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About 25% of patients who were successfully treated had a recurrence of C. difficococcal infection (CDI).
researchers conducted two phase 3 randomized double-blind trials at 154 locations in the United States, Canada and Europe, comparing fidasovamycin with vancomycin's treatment of CDI with CDI patients receiving 200 mg of non-dasomi, 2 times a day or 125 mg of vancomycin, 4 times a day for 10 days.
end point is the clinical cure of CDI at the end of treatment, and the secondary endpoint is the recurrence within 28 days of clinical cure.
results, a total of 1,164 subjects were included, of whom 128 subgroups in each group had recent CDI episodes before the CDI diagnosis at the time of the study.
analysis of the subgroup, the initial therapeutic response of the two drugs was similar .
However, 35.5 per cent of patients treated with vancomycin and 19.7 per cent of patients treated with non-dammycin relapsed within 28 days (difference of -15.8 per cent; 95 per cent confidence interval, -30.4 per cent to -0.3 per cent ;P s .045).
27 percent of patients treated with vancomycin reported early recurrence (within 14 days) in 27 percent of patients treated with vancomycin and those treated with non-dammycin (P .003).
the results showed that in patients with the first recurrence of CDI, Fidasomi was similar in clinical response to vancomycin at the end of treatment, but better than vancomycin in preventing a second recurrence within 28 days.
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