60 Participants Needed

Fidaxomicin vs Vancomycin for C. diff Infection

JA
AC
Overseen ByAlexander Carlin
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Fidaxomicin is as effective as Vancomycin in treating C. diff infections but is better at preventing the infection from coming back. Studies showed that patients treated with Fidaxomicin had fewer recurrences and a higher rate of sustained recovery compared to those treated with Vancomycin.12345

Is fidaxomicin safe for treating C. diff infections?

Fidaxomicin is generally safe for treating C. diff infections in adults, with a safety profile similar to vancomycin. It is well tolerated, with most patients experiencing mild gastrointestinal symptoms, and no serious safety concerns have been reported.15678

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

JA

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

Signed informed consent
I am over 18 years old.
I have been diagnosed with a form of inflammatory bowel disease.
See 1 more

Exclusion Criteria

I am unable to give my consent.
I have had surgery on my colon, such as a colectomy, ostomy, or J-pouch.
Allergy or sensitivity to vancomycin, fidaxomicin, or microcrystalline cellulose
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fidaxomicin or vancomycin for decolonization of C. difficile

10 days
Daily visits for medication administration

Follow-up

Participants are monitored for safety, efficacy, and clinical outcomes after treatment

26 weeks
Visits at weeks 4, 8, and 26

Treatment Details

Interventions

  • Fidaxomicin
  • Vancomycin
Trial Overview The study compares the safety and effectiveness of two antibiotics: Fidaxomicin (200 mg twice daily) versus Vancomycin (125 mg every 6 hours), both taken orally for 10 days, in IBD patients with C. difficile infection.
Participant Groups
2Treatment groups
Active Control
Group I: VancomycinActive Control1 Intervention
Vancomycin is glycopeptide antibiotic that has broad gram-positive coverage. The current approved dose is 125mg PO every 6 hours for 10 days. Appropriate dosing and tolerance of vancomycin is well defined in both healthy and hospitalized populations, as it is already approved and indicated by the FDA for use in treating C. difficile infection.
Group II: FidaxomicinActive Control1 Intervention
Fidaxomicin is a macrolide antibiotic. It is narrow spectrum with potent bactericidal activity specifically against C. difficile. The approved dose is 200mg PO twice daily for 10 days. Appropriate dosing and tolerance of fidaxomicin is well defined in both healthy and hospitalized populations, as it is already approved and indicated by the FDA for use in treating C. difficile infection.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

References

Fidaxomicin versus Vancomycin in the Treatment of Clostridium difficile Infection: Canadian Outcomes. [2020]
Fidaxomicin for the Treatment of Clostridioides difficile Infection in Adult Patients: An Update on Results from Randomized Controlled Trials. [2022]
Cost-effectiveness analysis of fidaxomicin versus vancomycin in Clostridium difficile infection. [2021]
Budget Impact Analysis of Fidaxomicin Versus Vancomycin for the Treatment of Clostridioides difficile Infection in the United States. [2022]
Fidaxomicin: in Clostridium difficile infection. [2021]
Safety analysis of fidaxomicin in comparison with oral vancomycin for Clostridium difficile infections. [2021]
Fidaxomicin for the Treatment of Clostridium Difficile Infection in the Pediatric Population - Not Quite So Soon Yet. [2020]
Fidaxomicin Use in the Pediatric Population with Clostridioides difficile. [2022]
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