Fidaxomicin vs Vancomycin for C. diff Infection
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on chronic antibiotics, you may not be eligible to participate.
What data supports the effectiveness of the drug Fidaxomicin compared to Vancomycin for C. diff infection?
Is fidaxomicin safe for treating C. diff infections?
How does the drug fidaxomicin differ from vancomycin in treating C. diff infection?
Fidaxomicin is unique because it specifically targets C. diff bacteria with minimal impact on normal gut bacteria, leading to fewer recurrences of infection compared to vancomycin. It is also taken less frequently, twice a day, and is poorly absorbed into the bloodstream, which reduces systemic side effects.13457
What is the purpose of this trial?
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.
Research Team
Jessica Allegretti, MD, MPH
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
This trial is for patients with Inflammatory Bowel Disease (IBD) who are also infected with C. difficile. Participants must meet certain health standards to be included, but specific inclusion and exclusion criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either fidaxomicin or vancomycin for decolonization of C. difficile
Follow-up
Participants are monitored for safety, efficacy, and clinical outcomes after treatment
Treatment Details
Interventions
- Fidaxomicin
- Vancomycin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor