Vancomycin Taper for Clostridium Difficile Colitis
(TAPER-V2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a specific method of administering the antibiotic vancomycin is as effective as fidaxomicin in preventing recurrent infections of C. difficile, a bacterium that causes gut issues. Participants will either take fidaxomicin for 10 days or follow a tapering schedule with vancomycin, gradually reducing the dose over several weeks. Adults who have experienced their first or second C. difficile infection and show symptoms like frequent diarrhea may qualify for participation. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that vancomycin, when used in gradually decreasing doses, is a well-tolerated treatment for Clostridium difficile infections (CDI). Patients often use this method to help prevent the infection from returning. This approach is commonly accepted for those experiencing their first recurrence of CDI. Research involving 174 patients suggested that using a tapered dose helps manage the condition safely.
Fidaxomicin, another treatment for CDI, is also well-tolerated. Patients usually take it twice a day for 10 days. Many report fewer side effects with fidaxomicin compared to other antibiotics for CDI. Both vancomycin and fidaxomicin have been used effectively, showing good safety records in past studies.
In summary, both treatments have been studied extensively and are generally safe for people with CDI. The choice between them often depends on specific patient needs and doctor's recommendations.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the Vancomycin Taper for Clostridium difficile colitis because it offers a unique dosing strategy aimed at reducing recurrence rates of the infection. Unlike the typical antibiotic treatments, which may not prevent relapse effectively, this tapering method gradually reduces the dose over several weeks, potentially allowing for a more sustained eradication of the bacteria. Additionally, this approach might help maintain a healthier gut microbiome balance, which is crucial in preventing future infections.
What evidence suggests that this trial's treatments could be effective for Clostridium difficile colitis?
Research has shown that using vancomycin in a tapered and pulsed regimen can effectively treat repeat Clostridioides difficile infections (rCDI). Some studies suggest that gradually reducing the dose of vancomycin over time can lower the chance of the infection returning. Although antibiotics like vancomycin work in about 40% to 50% of cases, this method remains a good option for treating a first recurrence of CDI. In this trial, participants will receive either the vancomycin tapered regimen or fidaxomicin, which has proven effective with a standard 10-day treatment. The trial aims to compare these two methods for managing first-time and repeat CDI cases.13678
Who Is on the Research Team?
Emily McDonald, MD MSc
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Todd Lee, MSc MPH
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Are You a Good Fit for This Trial?
Adults over 18 with a first episode or recurrence of C. difficile infection, who can take oral medication and meet Quebec's criteria for fidaxomicin coverage. Excluded are those in palliative care, likely to die within 3 months from another illness, pregnant or breastfeeding women, patients with severe allergies to the drugs being tested, and those without health insurance.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either vancomycin P-T or fidaxomicin for the treatment of first episodes and first recurrences of CDI
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on CDI recurrence
Extended Follow-up
Participants are monitored for all-cause mortality and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Fidaxomicin
- Vancomycin
Trial Overview
The trial is testing if a vancomycin pulse-taper regimen is as effective as a standard 10-day course of fidaxomicin in preventing recurrent Clostridioides difficile infections at day 56 after treatment starts.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Vancomycin 125mg PO QID x2 weeks, then 125mg PO BID x2 weeks, then 125mg PO daily x2 weeks
Fidaxomicin 200mg PO BID x 10 days
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Citations
Tapering Courses of Oral Vancomycin Induce Persistent ...
In summary, we found that a vancomycin tapered and pulsed regimen caused persistent disruption of the intestinal microbiota that provide ...
Study Details: Initial Vancomycin Taper for C. Diff Infection
The investigators hypothesize that by extending initial vancomycin therapy with a 2-week tapering regimen this will reduce the risk of rCDI.
Vancomycin for Recurrent C. diff: Efficacy, Safety, Tolerability
26% (n = 5) of individuals were cured, and 63% (n = 12) individuals had recurrence. Two individuals died from C. difficile related complications ...
My Treatment Approach to Clostridioides difficile Infection
The success of fecal microbiota transplantation is greater than 85%, compared with the 40% to 50% success rate of antibiotics in this situation.
C. difficile 2021 Focused Update
Comment: Vancomycin in a tapered and pulsed regimen or vancomycin as a standard course are acceptable alternatives for a first CDI recurrence.
Extended duration vancomycin in recurrent Clostridium ...
Outcomes were evaluable in 174 patients, 31 from randomized trials, with prior average recurrent episodes ranging from 3 to 4. Vancomycin dose ranged from 3500 ...
A Randomized, Double-Blind, Phase 3 Safety and Efficacy ...
These findings suggest that treatment of CDI with ridinilazole results in an earlier recovery of gut microbiome health. Clinical Trials ...
Treatment of Clostridioides difficile infection in adults ...
The dosing regimen is as follows: oral vancomycin 125 mg four times daily for 10-14 days, oral vancomycin 125 mg two times daily for 7 days, ...
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