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

Sponsor
Montefiore Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03937999
Collaborator
Merck Sharp & Dohme LLC (Industry)
50
Enrollment
1
Location
2
Arms
48.5
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Intervention group compared to concurrent and historical control groupsIntervention group compared to concurrent and historical control groups
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Pragmatic Trial of Secondary Prophylaxis With Bezlotoxumab to Prevent C. Difficile Relapse Among Hospitalized Adults Receiving Antibiotics.
Actual Study Start Date :
Aug 30, 2019
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bezlotoxumab Arm

Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0

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

    		•
    No Intervention: No Bezlotoxumab

    Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) .

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence of C.diff infection [within 4 weeks]

    Secondary Outcome Measures

    1. Recurrence of C. diff infection [within 8 weeks]

    2. Rate of deaths [within 8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montefiore Medical Center Bronx New York United States 10467

    Sponsors and Collaborators

    • Montefiore Medical Center
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Paul Riska, MD, Montefiore Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT03937999
    Other Study ID Numbers:
    • 2019-10212
    First Posted:
    May 6, 2019
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Montefiore Medical Center
    clostridium difficile
    diarrhea
    Additional relevant MeSH terms:
    Clostridium Infections

    Study Results

    No Results Posted as of Jun 14, 2022