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

NCT06794944 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-03

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Disease (IBD)
  • Clostridioides Difficile Infection

Interventions

DRUG

Vancomycin (POC)

Vancomycin is glycopeptide antibiotic that has broad gram-positive coverage. Patients will receive 125mg PO every 6 hours for 10 days.

DRUG

Fidaxomicin

Fidaxomicin is a macrolide antibiotic. It is narrow spectrum with potent bactericidal activity specifically against C. difficile. Patients will receive 200mg PO twice daily for 10 days.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Jessica Allegretti, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-09-01
Completion
2031-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794944 on ClinicalTrials.gov