Fidaxomicin vs Vancomycin for C. diff Infection

Overseen By Alexander Carlin

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Must not be taking: Antibiotics

Disqualifiers: Previous colon surgery, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two antibiotics, fidaxomicin and vancomycin, to determine which better treats C. difficile infections in people with inflammatory bowel disease (IBD). Researchers aim to identify which drug is safer and more effective at clearing the infection. Participants will be divided into two groups, each taking one of the antibiotics for 10 days. This trial may suit those diagnosed with IBD who plan to have an outpatient colonoscopy. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how these antibiotics can benefit more patients.

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 is the safety track record for these treatments?

Research shows that both fidaxomicin and vancomycin are well-tolerated treatments for C. difficile infections, often called "C. diff." Fidaxomicin, a narrow-spectrum antibiotic, specifically targets C. diff bacteria. Studies have shown it effectively treats infections, with high success rates and few side effects.

Vancomycin, a broader antibiotic, is also approved for treating C. diff. It has been used for a long time and is known to be safe. Patients generally tolerate it well, with side effects being rare and usually mild.

The FDA has approved both medications for treating C. diff infections, indicating their safety for this use. This approval provides confidence in the safety of these treatments in the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about fidaxomicin for treating C. diff infections because it offers a more targeted approach than the standard treatment options like vancomycin. Unlike vancomycin, which has a broad spectrum of action against many gram-positive bacteria, fidaxomicin specifically targets C. difficile, potentially leading to fewer side effects and less disruption of the normal gut flora. This narrow-spectrum approach helps preserve the beneficial bacteria in the gut, which may reduce the likelihood of recurrent infections — a significant issue with C. diff.

What is the effectiveness track record for fidaxomicin and vancomycin in treating C. diff infection?

This trial will compare Fidaxomicin and Vancomycin for treating C. difficile infections. Research has shown that fidaxomicin is more effective than vancomycin for this purpose. Studies found that patients using fidaxomicin had a lower chance of the infection returning, with a risk ratio of 0.52 compared to vancomycin. This indicates that fidaxomicin is less likely to see the infection return after treatment. Specifically, one study found that only 9.5% of patients treated with fidaxomicin experienced the main issue again, compared to 21.6% with vancomycin. Fidaxomicin also has a high success rate and results in fewer hospital readmissions. Both antibiotics are approved by the FDA for treating C. difficile, but fidaxomicin generally provides better long-term results. ^{2 3 5 6 7}

Who Is on the Research Team?

Jessica Allegretti, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 have been diagnosed with a form of inflammatory bowel disease.

I am scheduled for an outpatient colonoscopy.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Vancomycin Active Control 1 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: Fidaxomicin Active Control 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38779889/

The Clinical Effectiveness of Fidaxomicin Compared to ... The primary outcome occurred in 8 (9.5%) in the fidaxomicin group compared to 111 (21.6%) in the vancomycin group. The adjusted multivariable ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S266677622400320X

Articles Comparative effectiveness of different therapies for ... Focusing solely on recurrent cases, we identified FMT as the best therapy. FMT is followed by fidaxomicin. Both therapies showed significantly better results ...

3. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/fidaxomicin-underused-c-diff-infections-study-finds

Fidaxomicin underused for C diff infections, study finds From the pre-period to the post-period, fidaxomicin use increased from 5.9% to 13.7%, while vancomycin used declined from 87.9% to 82.9% and ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2024/08090/efficacy_of_fidaxomicin_versus_vancomycin_in_the.81.aspx

Efficacy of fidaxomicin versus vancomycin in the treatment... Results showed that fidaxomicin was superior to vancomycin in terms of 40-day recurrence rate (RR = 0.52, 95% CI: 0.38–0.70, P < .01, Fig. 4A), ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4280276/

Fidaxomicin Use and Clinical Outcomes for Clostridium ... In this real-world setting, fidaxomicin resulted in a high rate of clinical success, a low rate of recurrence, and a low readmission rate. Key Words: ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31773143/

Safety and Efficacy of Fidaxomicin and Vancomycin in ... Conclusions: Compared with vancomycin, fidaxomicin was well tolerated and demonstrated significantly higher rates of GC in children and adolescents with CDI.

7. idsociety.org idsociety.org/practice-guideline/clostridioides-difficile-2021-focused-update/

C. difficile 2021 Focused Update The panel agrees that the overall balance of benefits and harms favors using fidaxomicin over vancomycin for an initial episode of CDI and that ...