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

Phase 4

Terminated

• Conditions: Clostridium Difficile
• Interventions: Drug: Bezlotoxumab

• Registration Number: NCT03937999
• Lead Sponsor: Montefiore Medical Center

Brief 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.

Detailed Description

Clostridioides difficile (C. diff) is a germ (bacteria) that causes life-threatening diarrhea. It is usually a side-effect of taking antibiotics that affect the normal balance of bacteria in the intestines. When the "good bacteria" in the intestine are killed by antibiotics, the C.diff bacteria begin to grow and produce toxins, causing frequent diarrhea and other symptoms such as abdominal pain or tenderness, loss of appetite, low-grade fever, nausea and vomiting. C. diff can be treated by using special antibiotics, but it tends to come back in about 20% of patients. C-diff is problematic because of frequent relapses after apparent cure. The greatest risk factor for relapse is receipt of subsequent antibiotics, in the hospital, shortly after being treated.

Zinplava™(bezlotoxumab) is an FDA approved human monoclonal antibody designed to prevent the recurrence of C.diff.This is not an antibiotic, as it does not kill C. diff, but is an antibody to C. diff toxins, which stops the damage. When Bezlotoxumab is given during a C. diff infection together with antibiotics to kill C. diff, it decreases the risk that C. diff will come back by about one-half. Bezlotoxumab is approved for use when given during a C. diff infection, but it has not been used to prevent C diff in other situations, such as the one being studied in this research.

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-08-30
• Primary Completion: 2022-05-15
• Study Completion: 2022-05-15
• Results First Submitted: 2022-09-15
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-13
• Results First Posted: 2022-11-09
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bezlotoxumab Arm	Bezlotoxumab	Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0

Primary Outcome Measures

Name	Time	Method
Recurrence of C.Difficile Infection	within 4 weeks

Secondary Outcome Measures

Name	Time	Method
Recurrence of C.Difficile Infection	within 8 weeks
Rate of Deaths	within 8 weeks
Relapse of C. Difficile by 8 Weeks	8 weeks

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States