Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
Primary Purpose
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bezlotoxumab
Sponsored by
About this trial
This is an interventional prevention trial for Inflammatory Bowel Diseases focused on measuring C.diff, C. difficile, IBD, UC, Bezlotoxumab, Recurrent C. diff
Eligibility 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.
Sites / Locations
- University of Pittsburgh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Open label
Arm Description
Single arm
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change from 90 days in healthcare utilization after Bezlotoxumab at 12 months
Number of emergency department (ED) visits and hospital admissions per participant
Change from 12 months in healthcare utilization after Bezlotoxumab at 24 months
Number of emergency department (ED) visits and hospital admissions per participant
Change from 90 days in healthcare associated charges after Bezlotoxumab at 12 months
Total charges associated with healthcare utilization per participant
Change from 12 months in healthcare associated charges after Bezlotoxumab at 24 months
Total charges associated with healthcare utilization per participant
Full Information
NCT ID
NCT04626947
First Posted
September 29, 2020
Last Updated
September 13, 2023
Sponsor
David Binion, MD
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04626947
Brief Title
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
Official Title
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Binion, MD
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, C. Diff. Infections
Keywords
C.diff, C. difficile, IBD, UC, Bezlotoxumab, Recurrent C. diff
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open label
Arm Type
Other
Arm Description
Single arm
Intervention Type
Biological
Intervention Name(s)
Bezlotoxumab
Intervention Description
Bezlotoxumab infusion
Primary Outcome Measure Information:
Title
Number of participants with recurrent C. Diff infection at 90 days
Description
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Time Frame
90 days
Title
Number of participants with recurrent C. Diff infection at 12 months
Description
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Time Frame
12 months
Title
Number of participants with recurrent C. Diff infection at 24 months
Description
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change from baseline in inflammatory markers after Bezlotoxumab at 90 days
Description
Rates of abnormal C reactive protein (CRP), Erythrocyte sedimentation rate (ESR), and albumin defined by "out of normal range" by lab report.
Time Frame
Baseline, 90 days
Title
Change from 90 days in inflammatory markers after Bezlotoxumab at 12 months
Description
Rates of abnormal CRP,ESR, and albumin defined by "out of normal range" by lab report.
Time Frame
90 days, 12 months
Title
Change from 12 months in inflammatory markers after Bezlotoxumab at 24 months
Description
Rates of abnormal CRP,ESR, and albumin defined by "out of normal range" by lab report.
Time Frame
12 months, 24 months
Title
Change from baseline in disease activity scores after Bezlotoxumab at 90 days
Description
Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4.
Time Frame
Baseline, 90 days
Title
Change from baseline in disease activity scores after Bezlotoxumab at 90 days
Description
Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3.
Time Frame
Baseline, 90 days
Title
Change from 90 days in disease activity scores after Bezlotoxumab at 12 months
Description
Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4.
Time Frame
90 days, 12 months
Title
Change from 90 days in disease activity scores after Bezlotoxumab at 12 months
Description
Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3.
Time Frame
90 days, 12 months
Title
Change from 12 months in disease activity scores after Bezlotoxumab at 24 months
Description
Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4.
Time Frame
12 months, 24 months
Title
Change from 12 months in disease activity scores after Bezlotoxumab at 24 months
Description
Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3.
Time Frame
12 months, 24 months
Title
Change from baseline in disease related quality of life after Bezlotoxumab at 90 days
Description
Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
Time Frame
Baseline, 90 days
Title
Change from 90 days in disease related quality of life after Bezlotoxumab at 12 months
Description
Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
Time Frame
90 days, 12 months
Title
Change from 12 months in disease related quality of life after Bezlotoxumab at 24 months
Description
Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life.
Time Frame
12 months, 24 months
Title
Change from 90 days in healthcare utilization after Bezlotoxumab at 12 months
Description
Number of emergency department (ED) visits and hospital admissions per participant
Time Frame
90 days, 12 months
Title
Change from 12 months in healthcare utilization after Bezlotoxumab at 24 months
Description
Number of emergency department (ED) visits and hospital admissions per participant
Time Frame
12 months, 24 months
Title
Change from 90 days in healthcare associated charges after Bezlotoxumab at 12 months
Description
Total charges associated with healthcare utilization per participant
Time Frame
90 days, 12 months
Title
Change from 12 months in healthcare associated charges after Bezlotoxumab at 24 months
Description
Total charges associated with healthcare utilization per participant
Time Frame
12 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Ramos Rivers, MD
Phone
4126487402
Email
cmr95@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David Binion, MD
Phone
4123830571
Email
cmr95@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Binion, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Ramos Rivers
Phone
412-648-7402
Email
cmr95@pitt.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
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