Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection

Inclusion Criteria (Interventional): * i) age 18 years or older; * ii) diagnosis of multi-recurrent CDI, defined as passage of 3 or more loose stools in 24 hours or less for at least 2 consecutive days and a positive stool test for toxigenic C. difficile (nucleic acid amplification test \[NAAT\] and toxin enzyme immunoassay \[EIA\] positive), with 2 or more confirmed prior CDI episodes; * iii) receiving or planning to receive a 10- to 14-day course of SOC therapy with oral VAN followed by a tapered VAN regimen for at least 4 weeks; * iv) patient highly unlikely to become pregnant due to being female and not of reproductive potential or female of reproductive potential agreeing to be abstinent or using 2 acceptable methods of birth control starting at enrollment and through the 16-week study period; and * v) patient or legal representative voluntarily agreeing to participate by providing written informed consent after the nature of the study has been fully explained. Inclusion Criteria (Historical Control): * i) age 18 years or older * ii) diagnosis of multi-recurrent CDI * iii) received 10- to 14-day course of SOC therapy with oral VAN followed by a tapered VAN regimen. Exclusion Criteria: * i) active chronic diarrheal illness, such as (but not limited to) ulcerative colitis or Crohn's disease or with a condition such that they routinely pass loose stool * ii) planned surgery for CDI within 24 hours * iii) positive pregnancy test in the 48 hours before the infusion or unwilling to undergo pregnancy testing if a pre-menopausal female who is not sterilized and therefore has the potential to bear a child * iv) breastfeeding or planning to breastfeed prior to the completion of the study period * v) previous receipt of BEZLO * vi) receipt of immune globulin within 6 months prior to enrollment or planning to receive immune globulin prior to completion of the 16-week study period * vii) receipt of non-SOC CDI therapy within 14 days prior to enrollment * viii) planned treatment with SOC therapy for longer than 6 weeks * ix) receipt of medications to control diarrhea such as loperamide, diphenoxylate hydrochloride/atropine sulfate at any time prior to completion of the 16-week study period * x) medical history of decompensated congestive heart failure