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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2024-05-31

Brief Summary

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The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Open label

Single arm

Group Type OTHER

Bezlotoxumab

Intervention Type BIOLOGICAL

Bezlotoxumab infusion

Interventions

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Bezlotoxumab

Bezlotoxumab infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No