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

Phase 4

Terminated

• Conditions: Inflammatory Bowel Diseases; C. Diff. Infections; Ulcerative Colitis; Crohn Disease
• Interventions: Biological: Bezlotoxumab

• Registration Number: NCT04626947
• Lead Sponsor: David Binion, MD

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-13
• Study Start: 2021-10-14
• Primary Completion: 2024-04-24
• Study Completion: 2024-05-31
• Results First Submitted: 2025-04-04
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Results First Posted: 2025-06-05
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label	Bezlotoxumab	Single arm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days	90 days	Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 90 days from receiving Bezlotuxumab.
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months	12 months	Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 12 months from receiving Bezlotuxumab
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months	24 months	Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 24 months from receiving Bezlotuxumab
Quality of Life and Disease Activity Scores of Participants at Study Baseline	Index visit	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.
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days	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.
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months	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.
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months	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.
Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days	90 Days	Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 90 Days.
Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months	12 months	Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 12 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months	24 months	Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 24 months

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States