Bezlotoxumab for Prevention of Clostridium difficile Infection Recurrence
Clostridium difficile is the most common cause of infectious diarrhea in hospitalized patients in high-income countries. After treatment with antibiotic therapy, patients may have a recurrence of C. Difficile infection, which can be more difficult to treat and may lead to rehospitalisation. Circulating antibodies against toxin A and toxin B generated by C.difficile have been correlated with protection against primary and recurrent infection. MODIFY I and MODIFY II are two international randomized, double blind, placebo-controlled trials investigating the effect of monoclonal antibodies against C.difficile toxins to prevent recurrent infection.
Investigators evaluated actoxumab and bezlotoxumab, two fully human monoclonal antibodies that bind and neutralize C.difficile toxins A and B, respectively. 2655 patients with a median age of 66 years, who had primary or recurrent C.difficile infection and were receiving standard-of-care antibiotics were randomized to receive intravenous placebo, actoxumab, bezlotoxumab, or a combination of both monoclonal antibodies. The primary endpoint was the proportion with recurrent C.difficile -- a new episode after successful treatment of the initial infection -- over 12 weeks of follow up. After an interim analysis, enrollment in the actoxumab group was stopped owing to higher rates of recurrent C.difficile infection than in the combination monoclonal antibody group. In MODIFY I the number of patients with recurrent C.difficile was 17 % in the bezlotoxumab group as compared with 28% in the placebo group. The results were similar in MODIFY II, and the differences were significant in both studies. The rates of recurrent C.
Difficile infection were similar in the bezlotoxumab and combination groups. Common adverse events included diarrhea and nausea, which were similar across all study groups. The authors conclude that among patients receiving standard of care antibiotics for primary or recurrent C.difficile infection, bezlotoxumab alone or in combination reduced recurrent C.difficile infection rates as compared with placebo. Full trial results are available at NEJM.org.
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