Bezlotoxumab Versus FMT for Multiple Recurrent CDI

Inclusion Criteria:

• 18-90 years old
• diarrhea (3 or more unformed stools per 24h for two consecutive days; or >= 8 unformedstools per 48h) XML File Identifier: KqQEbBLRYEZjGgsIl5GcI+NXCyM= Page 10/22
• positive PCR test for toxin A/B genes and/or positive toxin EIA for current andprevious episodes (low PCR cycle threshold value when only PCR performed)
• a minimum of two prior CDI episodes
• previous episode is maximum of 3 months prior to the current episode
• the current episode responds well to Standard of Care treatment (vancomycin orfidaxomicin orally).
• Assessment of the severity of the disease will be performed according to the ESCMIDrecommendations.
• Both mild and severe CDI will be included

Exclusion Criteria:

• Severe complicated CDI, i.e presence of: hypotension, septic shock, elevated serumlactate, ileus, toxic megacolon, bowel perforation, or any fulminant course ofdisease.
• ICU admission for underlying disease
• pregnancy or current desire for pregnancy
• breastfeeding
• (prolonged) use of antibiotics (other than for treatment of CDI) during the studyperiod or directly after the intervention
• previous use of bezlotoxumab or fecal microbiota transplantation
• a history of underlying congestive heart failure (potential safety signal phase-IIItrail bezlotoxumab).
• Diagnosis of inflammatory bowel disease in medical history.