Vancomycin for C. diff Infection
(SPORES-V Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether oral vancomycin, an antibiotic, can prevent repeat Clostridioides difficile infections (CDI) when someone needs antibiotics again. Individuals who have had a CDI in the last 120 days and are currently taking antibiotics for another infection might be suitable candidates. Participants will receive either vancomycin or a placebo (a pill with no active medicine) alongside their antibiotics for a short period. The goal is to determine if vancomycin can prevent the infection from recurring. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, it seems you can continue taking systemic antibiotics as part of the study, but certain other treatments like fecal microbiota transplantation or specific antibiotics may exclude you from participating.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Studies have shown that oral vancomycin is generally well-tolerated. In one study, 69.2% of participants taking vancomycin reported side effects, similar to the 64.3% of participants who experienced side effects with a placebo. This indicates that side effects were common in both groups, but not significantly higher with vancomycin.
This treatment is often used to prevent the recurrence of Clostridioides difficile infections. While effective, some individuals do experience side effects. Most side effects are mild and similar to those seen with a placebo.
Vancomycin's presence in Phase 2 and Phase 3 trials indicates it has undergone earlier safety testing. Researchers have deemed it safe enough for testing on larger groups.12345Why do researchers think this study treatment might be promising?
Vancomycin is unique because it's being evaluated not just as a treatment for active C. diff infections but also as a prophylactic option to prevent infection during antibiotic re-exposure. Unlike standard treatments like metronidazole or fidaxomicin, which primarily target active infections, this approach with vancomycin aims to prevent the infection from happening in the first place. Researchers are excited about this because it could significantly reduce the recurrence rates of C. diff, offering a new strategy to keep patients infection-free while on antibiotics.
What evidence suggests that oral vancomycin might be an effective treatment for preventing CDI recurrences?
Research has shown that taking oral vancomycin with other antibiotics might help prevent the recurrence of Clostridioides difficile infection (CDI). In this trial, participants will receive either oral vancomycin or a placebo. One study found that 43.6% of those taking oral vancomycin experienced a recurrence, compared to 57.1% of those on a placebo, suggesting a possible benefit, though the difference was not substantial. Another study indicated that vancomycin reduced the chances of recurrence, but the results were not strong enough to rule out chance. Observational data, examining real-world use, also suggests that oral vancomycin might reduce the risk of CDI returning in individuals with a history of the infection.15678
Who Is on the Research Team?
Todd C. Lee, MD MPH
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Connor J. Prosty, MD
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Are You a Good Fit for This Trial?
This trial is for individuals who recently had a Clostridioides difficile infection (within the last 120 days) and are now taking systemic antibiotics, which could cause another C. diff infection. Participants must be willing to take study medication twice daily during antibiotic treatment and once daily for a week after, attend a follow-up visit on day 56, and complete weekly electronic questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take the study drug (either vancomycin or placebo) twice daily for the duration of systemic antibiotics plus once daily for 7 days after completion of systemic antibiotics.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including an in-person follow-up at day 56.
Extended Follow-up
Participants continue to be monitored for late CDI recurrence and other outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Vancomycin
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