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

• ClinicalTrials.gov Identifier: NCT04626947
• Recruitment Status: Recruiting
• First Posted: November 13, 2020
• Last Update Posted: September 14, 2022
• Sponsor: David Binion, MD
• Collaborator: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): David Binion, MD, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease; C. Diff. Infections	Biological: Bezlotoxumab	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
• Actual Study Start Date: October 30, 2021
• Estimated Primary Completion Date: December 30, 2023
• Estimated Study Completion Date: December 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Open label; Single arm	Biological: Bezlotoxumab; Bezlotoxumab infusion

Outcome Measures

Primary Outcome Measures :

1. Number of participants with recurrent C. Diff infection at 90 days [ Time Frame: 90 days ]
   Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
2. Number of participants with recurrent C. Diff infection at 12 months [ Time Frame: 12 months ]
   Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
3. Number of participants with recurrent C. Diff infection at 24 months [ Time Frame: 24 months ]
   Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.

Secondary Outcome Measures :

1. Change from baseline in inflammatory markers after Bezlotoxumab at 90 days [ Time Frame: 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.
2. Change from 90 days in inflammatory markers after Bezlotoxumab at 12 months [ Time Frame: 90 days, 12 months ]
   Rates of abnormal CRP,ESR, and albumin defined by "out of normal range" by lab report.
3. Change from 12 months in inflammatory markers after Bezlotoxumab at 24 months [ Time Frame: 12 months, 24 months ]
   Rates of abnormal CRP,ESR, and albumin defined by "out of normal range" by lab report.
4. Change from baseline in disease activity scores after Bezlotoxumab at 90 days [ Time Frame: Baseline, 90 days ]
   Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4.
5. Change from baseline in disease activity scores after Bezlotoxumab at 90 days [ Time Frame: Baseline, 90 days ]
   Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3.
6. Change from 90 days in disease activity scores after Bezlotoxumab at 12 months [ Time Frame: 90 days, 12 months ]
   Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4.
7. Change from 90 days in disease activity scores after Bezlotoxumab at 12 months [ Time Frame: 90 days, 12 months ]
   Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3.
8. Change from 12 months in disease activity scores after Bezlotoxumab at 24 months [ Time Frame: 12 months, 24 months ]
   Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4.
9. Change from 12 months in disease activity scores after Bezlotoxumab at 24 months [ Time Frame: 12 months, 24 months ]
   Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3.
10. Change from baseline in disease related quality of life after Bezlotoxumab at 90 days [ Time Frame: Baseline, 90 days ]
    Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
11. Change from 90 days in disease related quality of life after Bezlotoxumab at 12 months [ Time Frame: 90 days, 12 months ]
    Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
12. Change from 12 months in disease related quality of life after Bezlotoxumab at 24 months [ Time Frame: 12 months, 24 months ]
    Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
13. Change from 90 days in healthcare utilization after Bezlotoxumab at 12 months [ Time Frame: 90 days, 12 months ]
    Number of emergency department (ED) visits and hospital admissions per participant
14. Change from 12 months in healthcare utilization after Bezlotoxumab at 24 months [ Time Frame: 12 months, 24 months ]
    Number of emergency department (ED) visits and hospital admissions per participant
15. Change from 90 days in healthcare associated charges after Bezlotoxumab at 12 months [ Time Frame: 90 days, 12 months ]
    Total charges associated with healthcare utilization per participant
16. Change from 12 months in healthcare associated charges after Bezlotoxumab at 24 months [ Time Frame: 12 months, 24 months ]
    Total charges associated with healthcare utilization per participant

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Claudia Ramos Rivers, MD; 4126487402; cmr95@pitt.edu

Contact: David Binion, MD; 4123830571; cmr95@pitt.edu

Locations

United States, Pennsylvania

University of Pittsburgh Medical Center; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Claudia Ramos Rivers 412-648-7402 cmr95@pitt.edu

Sponsors and Collaborators

David Binion, MD

Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: David Binion, MD; University of Pittsburgh

More Information

• Responsible Party: David Binion, MD, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04626947
• Other Study ID Numbers: STUDY19100301
• First Posted: November 13, 2020
• Last Update Posted: September 14, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by David Binion, MD, University of Pittsburgh:

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

Additional relevant MeSH terms:

Inflammatory Bowel Diseases; Infections; Communicable Diseases; Clostridium Infections; Crohn Disease; Intestinal Diseases; Disease Attributes; Pathologic Processes; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses