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Bezlotoxumab is indicated to reduce recurrence of Clostridioides difficile infection in people who are receiving antibacterial drug treatment for Clostridioides difficile infection and are at a high risk for Clostridioides difficile infection recurrence. [3]
Clostridioides difficile infection [5] (CDI or C-diff), also known as Clostridium difficile infection, is a symptomatic infection due to the spore-forming bacterium Clostridioides difficile. [6] Symptoms include watery diarrhea, fever, nausea, and abdominal pain. [1] It makes up about 20% of cases of antibiotic-associated diarrhea. [1]
FMT is an effective treatment for Clostridioides difficile infection (CDI). [3] [4] [5] For recurrent CDI, FMT is more effective than vancomycin alone, and may improve the outcome after the first index infection. [3] [5] [6] Side effects may include a risk of infections, therefore the donor should be screened for pathogens. [7]
Bezlotoxumab is a human monoclonal antibody designed for the prevention of recurrence of Clostridium difficile infections. By x-ray crystallized structure of N-terminal of TcdB, the toxin is identified to consist of three domains: a glucosyltransferase domain (GTD), a cysteine protease and a combined repetitive oligopeptide (CROP) domain.
Clostridioides difficile (syn. Clostridium difficile) is a bacterium known for causing serious diarrheal infections, and may also cause colon cancer. [4] [5] It is known also as C. difficile, or C. diff (/ s iː d ɪ f /), and is a Gram-positive species of spore-forming bacteria. [6]
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The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
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