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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937999
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval)
First Posted : May 6, 2019
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Paul Riska, 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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Drug: Bezlotoxumab 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention 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 : August 30, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: 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) .



Primary Outcome Measures :
  1. Recurrence of C.diff infection [ Time Frame: within 4 weeks ]

Secondary Outcome Measures :
  1. Recurrence of C. diff infection [ Time Frame: within 8 weeks ]
  2. Rate of deaths [ Time Frame: within 8 weeks ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937999


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Paul Riska, MD Montefiore Medical Center
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Responsible Party: Paul Riska, Principal Investigator, Dept of Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03937999    
Other Study ID Numbers: 2019-10212
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Paul Riska, Montefiore Medical Center:
clostridium difficile
diarrhea
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections