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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, C. Diff. Infections

Intervention / Treatment
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* Biological: Bezlotoxumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open label<br>Single arm | Biological: Bezlotoxumab<br>* Bezlotoxumab infusion<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| Change from baseline in inflammatory markers after Bezlotoxumab at 90 days | Rates of abnormal C reactive protein (CRP), Erythrocyte sedimentation rate (ESR), and albumin defined by out of normal range by lab report. | Baseline, 90 days | 
| Change from 90 days in inflammatory markers after Bezlotoxumab at 12 months | Rates of abnormal CRP,ESR, and albumin defined by out of normal range by lab report. | 90 days, 12 months | 
| Change from 12 months in inflammatory markers after Bezlotoxumab at 24 months | Rates of abnormal CRP,ESR, and albumin defined by out of normal range by lab report. | 12 months, 24 months | 
| Change from baseline in disease activity scores after Bezlotoxumab at 90 days | Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4. | Baseline, 90 days | 
| Change from baseline in disease activity scores after Bezlotoxumab at 90 days | Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3. | Baseline, 90 days | 
| Change from 90 days in disease activity scores after Bezlotoxumab at 12 months | Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4. | 90 days, 12 months | 
| Change from 90 days in disease activity scores after Bezlotoxumab at 12 months | Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3. | 90 days, 12 months | 
| Change from 12 months in disease activity scores after Bezlotoxumab at 24 months | Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4. | 12 months, 24 months | 
| Change from 12 months in disease activity scores after Bezlotoxumab at 24 months | Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3. | 12 months, 24 months | 
| Change from baseline in disease related quality of life after Bezlotoxumab at 90 days | Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life. | Baseline, 90 days | 
| Change from 90 days in disease related quality of life after Bezlotoxumab at 12 months | Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life. | 90 days, 12 months | 
| Change from 12 months in disease related quality of life after Bezlotoxumab at 24 months | Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life. | 12 months, 24 months | 
| Change from 90 days in healthcare utilization after Bezlotoxumab at 12 months | Number of emergency department (ED) visits and hospital admissions per participant | 90 days, 12 months | 
| Change from 12 months in healthcare utilization after Bezlotoxumab at 24 months | Number of emergency department (ED) visits and hospital admissions per participant | 12 months, 24 months | 
| Change from 90 days in healthcare associated charges after Bezlotoxumab at 12 months | Total charges associated with healthcare utilization per participant | 90 days, 12 months | 
| Change from 12 months in healthcare associated charges after Bezlotoxumab at 24 months | Total charges associated with healthcare utilization per participant | 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, C.diff, C. difficile, UC, Bezlotoxumab, Recurrent C. diff