Preventing C. difficile recurrence with short-course oral vancomycin during later antibiotics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2/3 trial enrolls adults who had a confirmed C. difficile infection within the past 120 days and who are being re-exposed to systemic antibiotics. Participants are randomized to receive oral vancomycin or placebo twice daily for the duration of the systemic antibiotic course and then once daily for seven days after antibiotics stop. Outcomes include occurrence of recurrent CDI through a follow-up visit at day 56 and weekly electronic questionnaires. The trial is led by the McGill University Health Centre and conducted at their Montreal site.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.
2. An episode of CDI within the preceding 120 days, diagnosed by both a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme immunoassay, and/or cell cytotoxicity neutralization assay) and the presence of either ≥3 unformed stools in \<24 hours with a duration \>24 hours, endoscopic/histologic evidence of pseudomembranous colitis, or ileus.
3. Treatment of the qualifying CDI episode with vancomycin or fidaxomicin for ≥10 days, and achievement of clinical cure (≤3 unformed stool per 24 hours in ≥2 days10).
4. Receipt of ≤3 days of at least one oral or intravenous systemic antibiotic, for which therapy is planned for at least one additional consecutive day in duration.

Clinical Exclusion Criteria

1. ≥72 hours of off-study vancomycin prophylaxis for the current episode of antibiotic re-exposure.
2. ≤1 day elapsed since discontinuation of CDI treatment
3. Treatment of the qualifying episode of CDI with metronidazole monotherapy or intravenous immunoglobulins.
4. Planned treatment with or treatment of the qualifying episode of CDI with fecal microbiota transplantation (FMT), bezlotoxumab, VOWST, REBYOTA, or another microbiome agent.
5. Inability to take medications orally.
6. Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.
7. Severe intolerance or allergy to oral vancomycin.
8. Lack of achievement of clinical cure during the treatment of the qualifying CDI episode
9. The qualifying antibiotic is solely for prophylaxis (e.g., once daily trimethoprim sulfamethoxazole) or the patient is anticipated to require systemic antibiotics for \>4 weeks (e.g., lifelong suppressive therapy or for the treatment of left-sided endocarditis or a deep-seated abscess).
10. Patients on ongoing systemic antibiotics since the completion of treatment for the qualifying episode of CDI that have not been interrupted by at least one day.
11. Patients admitted to a palliative care ward or who are anticipated to die within 8 weeks of enrollment from another illness.
12. The qualifying antibiotic is non-systemic (i.e., topical) or is not considered a significant risk factor for CDI including: single-dose antibiotics, as well as macrolides, nitrofurantoin, intravenous vancomycin, metronidazole, tetracyclines, and oral fosfomycin. If two or more systemic antibiotics are given (i.e., ceftriaxone and azithromycin), as long as at least one of the systemic antibiotics does not meet exclusion criteria, then the patient will still be eligible.
13. Concomitant receipt of rifaximin (e.g., for hepatic encephalopathy).
14. Receipt of ≥2 courses of vancomycin prophylaxis since the qualifying episode of CDI or \<2 weeks since the last course of vancomycin prophylaxis.
15. Treating team declined participation.

Administrative Exclusion Criteria

1. Prior enrollment in this trial.
2. Inability to consent and without a healthcare proxy.
3. Lack of health insurance.
4. Anticipated transfer to a site not involved in this trial or to a palliative care ward.
5. Patient declared anticipated inability to participate in study follow-up or lack of means for contact in the outpatient setting.

Where it's running

• McGill University Health Centre
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Todd C. Lee, MD MPH — McGill University Health Centre/Research Institute of the McGill University Health Centre
• Study coordinator: Emily G. McDonald, MD MSc
• Email: cdi@idtrials.ca
• Phone: 514-934-1934

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VE303 for preventing recurrent Clostridioides difficile infections

  This study is testing a new treatment called VE303 to see if it can help prevent Clostridioides difficile infections from coming back in people who are at high risk.

  Recruiting at 130 sites Phase 3 Vedanta Biosciences, Inc. · Huntsville, Alabama and 214 other locations · NCT06237452

• Diet and counseling to see how meals affect gut health after CDI

  We’re testing whether different meal plans and health counseling can influence the gut microbiome and reduce chances of CDI coming back in adults who are being treated for CDI.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07613645

• Oral donor fecal capsules for recurrent C. difficile infection

  This study tests whether taking donor fecal (FMT) capsules can prevent further C. difficile recurrences in adults who have already had at least two episodes.

  Recruiting Phase 3 Helsinki University Central Hospital · Helsinki, Uusimaa · NCT07458984

• Lyophilized fecal microbiota transplant for adults with active ulcerative colitis

  This trial will test whether a dried (lyophilized) fecal microbiota transplant helps adults with active ulcerative colitis when added to their current treatment or started alongside a new advanced medication.

  Recruiting Phase 1 University of Alberta · Calgary, Alberta and 1 other locations · NCT07401680

• How antibiotics versus fecal transplants affect recovery from C. difficile infection

  This project will see how antibiotics and fecal microbiota transplant (FMT) affect adults with C. difficile infection by tracking recovery and biological changes over time.

  Recruiting Umeå University · Umeå · NCT07374094

• Preventing recurrent C. difficile infection with the AZD5148 antibody

  This will try a single dose of the antibody AZD5148 versus placebo to see if it prevents repeat C. difficile infections in adults being treated for a current infection.

  Recruiting at 95 sites Phase 2 AstraZeneca · Phoenix, Arizona and 116 other locations · NCT07285213

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.