Vancomycin for C. diff Infection

(SPORES-V Trial)

Overseen By Emily G. McDonald, MD MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must not be taking: Metronidazole, Immunoglobulins, FMT, others

Disqualifiers: Total colectomy, Severe vancomycin allergy, others

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

Compensation: Varies

Number of Visits: 91

Duration: Duration of systemic antibiotics + 7 days

300 Participants Needed

Trial Summary

What is the purpose of this trial?

Re-exposure to systemic antibiotics (i.e., antibiotics absorbed into the bloodstream) is common after a Clostridioides difficile infection (CDI) and is the strongest risk factor for a recurrent episode. Oral vancomycin to prevent a recurrence during antibiotic re-exposure may reduce this risk but the data supporting this practice are limited. The aim of this trial is: 1) Does oral vancomycin prophylaxis prevent CDI recurrences in patients with recent CDI (within 120 days) and who are re-exposed to systemic antibiotics? The trial will compare oral vancomycin to placebo. Participants will: * 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. * Attend an in-person follow-up at day 56 * Respond to weekly electronic questionnaires

Research Team

Connor J. Prosty, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Todd C. Lee, MD MPH

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

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

I was treated for CDI with specific antibiotics for over 10 days and got better.

I am 18 or older and receiving care at a participating hospital.

I've taken antibiotics for an infection for 3 days or less.

Exclusion Criteria

I have had or will have treatment with FMT, bezlotoxumab, VOWST, or REBYOTA.

My last treatment for C. diff infection didn't work.

I cannot take medications by mouth or through a tube in my nose.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Duration of systemic antibiotics + 7 days

Weekly electronic questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment, including an in-person follow-up at day 56.

56 days

1 visit (in-person) at day 56

Extended Follow-up

Participants continue to be monitored for late CDI recurrence and other outcomes.

90 days

Surveys up to day 90

Treatment Details

Interventions

• Vancomycin

Trial Overview The trial aims to determine if oral vancomycin can prevent recurrent C. diff infections in patients who have been re-exposed to systemic antibiotics following a recent infection. It involves comparing the effectiveness of oral vancomycin prophylaxis with a placebo under these conditions.

Participant Groups

Group I: Oral Vancomycin Prophylaxis Experimental Treatment 1 Intervention

Vancomycin 125mg PO BID for the duration of antibiotic re-exposure + 125mg PO QD for 7 days

Group II: Placebo Placebo Group 1 Intervention

2 capsules PO BID for the duration of antibiotic re-exposure + 1 capsule PO QD for 7 days

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+