Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection

February 26, 2023 updated by: Eric R Wenzler, University of Illinois at Chicago
This is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard C. difficile infection (CDI) treatment compared to standard CDI treatment alone in patients with CDI seen in an academic medical center's specialty outpatient clinic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This specialty clinic is a unique practice setting where patients with ≥1 recurrent CDI and/or refractory disease are referred. The study will represent real-world data on the clinical use of bezlotoxumab as adjunctive therapy in combination with vancomycin or fidaxomicin for the treatment of patients with recurrent CDI. Retrospective chart review will be conducted for patients who visited the specialty CDI clinic between 1/1/2005 through 12/5/2019. Case patients will be defined as patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment. Controls will be defined as patients who have received only standard CDI treatment and will be enrolled in a 2:1 ratio to cases. The primary outcome is recurrence of CDI. Recurrence is defined as a new episode of C. difficile infection that occurs after the initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or standard CDI treatment. Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy. Recurrent CDI will be diagnosed via clinical signs and symptoms and CDI diagnostic assay.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being treated for C. difficile infection

Description

Inclusion Criteria (Cases):

  • Age 18 years and older
  • Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
  • Received bezlotoxumab in addition to standard CDI treatment

Inclusion Criteria (Controls):

  • Age 18 years and older
  • Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
  • Received only standard CDI treatment

Exclusion Criteria:

  • Diarrhea due to causes other than C. difficile
  • Incomplete documentation in the electronic medical record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment.
Biological: Bezlotoxumab
Bezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment
Controls
Patients who have received only standard CDI treatment.
Drug: Standard CDI treatment
Standard CDI treatment includes one or a combination of oral vancomycin, oral vancomycin taper and/or pulse, fidaxomicin, and fidaxomicin taper and/or pulse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of CDI Recurrence
Time Frame: within 12 weeks of receipt of bezlotoxumab
New episode of C. difficile infection that occurs after initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or completion of standard CDI treatment.
within 12 weeks of receipt of bezlotoxumab

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure
Time Frame: 2 consecutive days after completion of standard-of-care CDI therapy.
Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy.
2 consecutive days after completion of standard-of-care CDI therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Eric R Wenzler, PharmD, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Actual)

February 22, 2023

Study Completion (Actual)

February 22, 2023

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 26, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1381

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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