MedicalResearch.com: What is the background for this study? How does Bezlotoxumab differ from other medications for recurrent C. difficile infections?
Response: Clostridium difficile infection (CDI) is now the most common hospital acquired infection in the United States, accounting for significant morbidity and mortality, not only in the US, but around the world. Despite standard antibiotic therapy targeting the Clostridium difficile bacterium directly, recurrent infection is common, occurring in a quarter to a third of patients, often frail individuals with other concurrent medical problems. These patients can have multiple recurrences leading to their progressive deterioration over time. Until recently, the only treatment for CDI included antibiotics. More recently, fecal microbiota transplant is a promising, but as yet, FDA unapproved therapy. Bezlotoximab is a new FDA approved treatment for recurrent Clostridium difficile infection (rCDI) that compliments standard antibiotics. Bezlotoxumab is a monoclonal antibody targeting toxin B produced by Clostridium difficile during CDI. In two large treatment trials, bezotoxumab, in addition to standard-of-care antibiotics, reduced the frequency of CDI recurrences from about 28% to about 18%. In this study, we set out to see if this new drug performed as well in actual clinical practice as it did in the published clinical trials.