Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
NCT04626947 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2025-06-05
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
Interventions
- BIOLOGICAL
-
Bezlotoxumab
Bezlotoxumab infusion
Sponsors & Collaborators
- collaborator INDUSTRY
-
David Binion, MD
lead OTHER
Principal Investigators
-
David Binion, MD · University of Pittsburgh
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-14
- Primary Completion
- 2024-04-24
- Completion
- 2024-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
NCT01513239 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.
NCT03756454 ·Status: TERMINATED ·Phase: PHASE4
-
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
NCT03829475 ·Status: COMPLETED ·Phase: PHASE2
-
Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients
NCT01813500 ·Status: COMPLETED
-
Use of Bismuth Subsalicylate in Clostridium Difficile Colitis
NCT03592082 ·Status: WITHDRAWN ·Phase: PHASE4
-
The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection
NCT04675723 ·Status: COMPLETED
-
Small Bowel Transit Time in Clostridium Difficile Colitis
NCT01309750 ·Status: TERMINATED
-
Fecal Transplant for Relapsing C. Difficile Infection
NCT01703494 ·Status: UNKNOWN ·Phase: PHASE2
-
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
NCT03182907 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
NCT02784002 ·Status: COMPLETED ·Phase: PHASE2
-
Response of Clostridium Difficile Infection to Metronidazole Therapy
NCT00304369 ·Status: COMPLETED
-
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
NCT07250724 ·Status: RECRUITING
-
Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody
NCT00304408 ·Status: COMPLETED
-
Treatment for Clostridium-difficile Infection With IMM529
NCT03065374 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
NCT01241552 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
NCT01259726 ·Status: COMPLETED ·Phase: PHASE2
-
Study on Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease
NCT04179201 ·Status: UNKNOWN
-
Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection
NCT03880539 ·Status: COMPLETED ·Phase: PHASE4
-
The Clostridioides Difficile Trial of REC-3964
NCT06536465 ·Status: TERMINATED ·Phase: PHASE2
-
Pathogenic Mechanisms in C Diff Infection and Colitis
NCT01930032 ·Status: COMPLETED
-
Treatment of Recurrent Clostridium Difficile Infection With RBX7455
NCT02981316 ·Status: COMPLETED ·Phase: PHASE1
-
Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection
NCT05304715 ·Status: COMPLETED ·Phase: PHASE2
-
Defined Fecal Microbiota Transplantation for Clostridium Difficile Diarrhea
NCT01868373 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1
-
Immune Response to C.Difficile Infection
NCT02797288 ·Status: UNKNOWN
-
The ICON Study: Outcomes After FMT for Patients With IBD and CDI
NCT03106844 ·Status: COMPLETED ·Phase: PHASE1/PHASE2