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: Recruiting
• 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 (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Claudia Ramos Rivers, MD; Phone Number: 4126487402; Email: cmr95@pitt.edu
• Study Contact Backup: Name: David Binion, MD; Phone Number: 4123830571; Email: cmr95@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Claudia Ramos Rivers; Phone Number: 412-648-7402; Email: cmr95@pitt.edu

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
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

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 30, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 30, 2025

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 (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

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