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Could a simple antibiotic taper stop c. diff relapse?

NCT ID NCT04138706

Prevention Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether extending standard vancomycin treatment for C. diff infection with a 2-week taper (lowering the dose gradually) reduces the chance of the infection returning. 263 adults who had a first episode or first recurrence of C. diff were randomly assigned to receive either a vancomycin taper or a placebo after the initial 14-day treatment. The goal was to see if the taper lowers recurrence rates within 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vancomycin
What this could lead to
If it works, this simple, low-cost approach could help prevent C. diff from coming back after initial treatment.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. The taper may not reduce recurrence significantly, and some patients may still relapse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

263 people

The number who actually took part.

Started

Nov 2020

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All consecutive adult patients (inpatients and outpatients) who have a treated first episode or first recurrence of CDI. * CDI will be defined by a positive PCR for toxin gene and/or detection of toxin by EIA or CCA along with three or more episodes of diarrhea within 24 hours * Patients with a positive test with less than three bowel movements may be included if they initially presented with ileus or if they had pseudomembranous colitis visualized on colonoscopy Exclusion Criteria: * Clinical: 1. Toxic megacolon at presentation not resolved by day 10 2. For the current episode of CDI: use of metronidazole monotherapy\*, fidaxomicin, fecal microbiota transplant or intravenous immunoglobulins \*Participants may be eligible if they are initially treated with metronidazole but switch to oral vancomycin within 3 days (i.e. maximum 3 days of metronidazole monotherapy). 3. Previous or current colectomy 4. Severe allergy/intolerance to oral vancomycin 5. Patient is expected to die within 3 months from another disease or is expected to be admitted to a palliative care unit 6. Failure to achieve clinical cure (as above) by day 10 7. More than 2 episodes of C. difficile in the last 5 years. 8. Documented history of sensorineural hearing loss (other than presbycusis and noise induced hearing loss). The following patients with documented previous subtypes of sensorineural hearing loss will be excluded from the trial: Menière's disease, multiple sclerosis affecting auditory nerves, otic syphilis, viral cochleitis, autoimmune disorders, previous drug induced hearing loss, and otherwise unexplained sudden sensorineural hearing loss (SSNHL) 9. Known pregnancy or planning to become pregnant during the study period 10. Women who are breast feeding * Administrative: 1. Expected transfer to a palliative care unit or non-study hospital; 2. No provincial health insurance 3. Previously enrolled 4. No reliable means of outpatient contact 5. Incompetent without healthcare proxy 6. Patient stated inability to come to follow up appointments.

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Clostridium infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clostridium difficile infection

Contacts and locations

Locations

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Health Sciences Centre - Eastern Health

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • McGill University Health Centre (Royal Victoria Hospital)

    Montreal, Quebec, H4A3J1, Canada

  • Michael Garron Hospital

    Toronto, Ontario, M4C 3E7, Canada

  • St Joseph's Health Care

    Toronto, Ontario, M6R 1B5, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9, Canada

  • University Health Network

    Toronto, Ontario, M5G 1L7, Canada

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

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