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

Clostridium Difficile Clinical Trial

Official title:

A Pragmatic Trial of Secondary Prophylaxis With Bezlotoxumab to Prevent C. Difficile Relapse Among Hospitalized Adults Receiving Antibiotics.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03937999
• Other study ID #: 2019-10212
• Status: Terminated
• Phase: Phase 4
• Start date: August 30, 2019
• Est. completion date: May 15, 2022

Study information

• Verified date: October 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections

Intervention

Drug:
• Bezlotoxumab
Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of C.Difficile Infection		within 4 weeks
Secondary	Recurrence of C.Difficile Infection		within 8 weeks
Secondary	Rate of Deaths		within 8 weeks
Secondary	Relapse of C. Difficile by 8 Weeks		8 weeks