Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).

The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.

Study Overview

• Status: Terminated
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; C. Diff. Infections
• Intervention / Treatment: Biological: Bezlotoxumab

Detailed Description

Bezlotoxumab is administered during a course of antibiotic therapy. The dose is administered as one time treatment. Patients will receive 10 mg/kg IV over 60 minutes as a single dose via central line.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >18 years old
• active CDI receiving therapy
• diagnosis of IBD
• and history of CDI.

Exclusion Criteria:

• <18 years old
• no IBD
• no CDI
• history of colectomy
• history of preexisting congestive heart failure
• pregnant or nursing women
• TCP<50
• past cardiac history.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open label; Single arm	Biological: Bezlotoxumab; Bezlotoxumab infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Recurrent C. Diff Infection at 90 Days	Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.	90 days
Number of Participants With Recurrent C. Diff Infection at 12 Months	Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.	12 months
Number of Participants With Recurrent C. Diff Infection at 24 Months	Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days	Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 90 days from receiving Bezlotuxumab.	90 days
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months	Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 12 months from receiving Bezlotuxumab	12 months
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months	Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 24 months from receiving Bezlotuxumab	24 months
Quality of Life and Disease Activity Scores of Participants at Study Baseline	Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.	Index visit
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days	Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.	90 Days
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months	Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.	12 months
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months	Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.	24 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days	Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 90 Days.	90 Days
Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months	Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 12 months	12 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months	Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 24 months	24 months

Collaborators and Investigators

• Sponsor: David Binion, MD
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: David Binion, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): April 24, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: IBD; C.diff; Bezlotoxumab; UC; C. difficile; Recurrent C. diff
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Clostridium Infections; Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: STUDY19100301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: No