Overview

Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients with Inflammatory Bowel Disease

Status:
NOT_YET_RECRUITING

Trial end date:
2031-09-01

Target enrollment:

Participant gender:

Summary

This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days. The fidaxomicin arm will receive 200 mg PO BID for 10 days. In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells. In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days. Microbiome assessment and C. difficile testing will be performed at baseline, day 5, day 10, and weeks 4, 8, and 26.

Phase:

PHASE4

Details

Lead Sponsor:

Brigham and Women's Hospital

Treatments:

Fidaxomicin
Vancomycin