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: 2021-10-30
• Primary Completion: 2024-04-24
• Study Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07

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 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.
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.

Secondary Outcome Measures

Name	Time	Method
Change from 12 months in healthcare associated charges after Bezlotoxumab at 24 months	12 months, 24 months	Total charges associated with healthcare utilization per participant
Change from 12 months in disease activity scores after Bezlotoxumab at 24 months	12 months, 24 months	Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI \>3.
Change from 90 days in healthcare utilization after Bezlotoxumab at 12 months	90 days, 12 months	Number of emergency department (ED) visits and hospital admissions per participant
Change from 90 days in healthcare associated charges after Bezlotoxumab at 12 months	90 days, 12 months	Total charges associated with healthcare utilization per participant
Change from 12 months in inflammatory markers after Bezlotoxumab at 24 months	12 months, 24 months	Rates of abnormal CRP,ESR, and albumin defined by "out of normal range" by lab report.
Change from 12 months in disease related quality of life after Bezlotoxumab at 24 months	12 months, 24 months	Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
Change from baseline in inflammatory markers after Bezlotoxumab at 90 days	Baseline, 90 days	Rates of abnormal C reactive protein (CRP), Erythrocyte sedimentation rate (ESR), and albumin defined by "out of normal range" by lab report.
Change from baseline in disease related quality of life after Bezlotoxumab at 90 days	Baseline, 90 days	Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
Change from 90 days in disease related quality of life after Bezlotoxumab at 12 months	90 days, 12 months	Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
Change from 90 days in inflammatory markers after Bezlotoxumab at 12 months	90 days, 12 months	Rates of abnormal CRP,ESR, and albumin defined by "out of normal range" by lab report.
Change from baseline in disease activity scores after Bezlotoxumab at 90 days	Baseline, 90 days	Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI \>3.
Change from 90 days in disease activity scores after Bezlotoxumab at 12 months	90 days, 12 months	Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI \>3.
Change from 12 months in healthcare utilization after Bezlotoxumab at 24 months	12 months, 24 months	Number of emergency department (ED) visits and hospital admissions per participant

Trial Locations

Locations (1)

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