Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.

• Status: Recruiting
• Trial end date: 2022-09-15
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Anti-Bacterial Agents; Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• C diff diagnosed within 90 days

• Receipt of high-risk antibiotics for C diff (e.g. Beta-lactams, carbapenems) in an inpatient setting

• Age 60 years and older

Exclusion Criteria:

• Receipt of current C.diff active antibiotics (oral vancomycin, fidaxomycin, metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs.

• Not Expected to survive 8 weeks

• Prior or planned fecal microbiota transplant or Bezlotoxumab use

• Congestive heart failure (a potential risk of Bezlotoxumab)