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

David Binion, MD

Status and phase: Terminated; Phase 4

Conditions: C. Diff. Infections; Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Biological: Bezlotoxumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04626947

STUDY19100301

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Open label

Other group

Description:

Single arm

Treatment:

Biological: Bezlotoxumab