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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04626947
• Other study ID #: STUDY19100301
• Status: Terminated
• Phase: Phase 4
• Start date: October 30, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 31, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• C. Diff. Infections
• Clostridium Infections
• Communicable Diseases
• Crohn Disease
• Infections
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Biological:
• Bezlotoxumab
Bezlotoxumab infusion

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
David Binion, MD	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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