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

This is an interventional treatment trial for Clostridium Difficile Infection Recurrence focused on measuring C.diff, Clostridium Difficile, recurrence, Bezlotoxumab, CDI Read More

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