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

NCT04626947 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY19100301
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease; C. Diff. Infections

Keywords

C.diff; C. difficile; IBD; UC; Bezlotoxumab; Recurrent C. diff

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days

  90 days

• Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months

  12 months

• Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months

  24 months

• Quality of Life and Disease Activity Scores of Participants at Study Baseline

  Index visit

• Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days

  90 Days

Study Arms (1)

Open label

OTHER

Single arm

Biological: Bezlotoxumab

Interventions

Bezlotoxumab BIOLOGICAL

Bezlotoxumab infusion

Open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• David Binion, MD: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Clostridium Infections

Interventions

bezlotoxumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: David G. Binion
• Organization: University of Pittsburgh

binion@pitt.edu

412-647-4194

Study Officials

• David Binion, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 13, 2020
• Study Start: October 14, 2021
• Primary Completion: April 24, 2024
• Study Completion: May 31, 2024
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)