Status:
COMPLETED
Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
The first line therapy for an initial episode of CDI (Clostridium difficile infection) is 10-14 days of oral vancomycin which is now recommended over metronidazole in the 2018 guidelines from the Asso...
Detailed Description
STUDY POPULATION This is a multi-centre study involving institutions in British Columbia, Ontario, Quebec and Newfoundland. The study population will be drawn from patients cared for as inpatients or...
Eligibility Criteria
Inclusion
- 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
- Clinical:
- Toxic megacolon at presentation not resolved by day 10
- 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).
- Previous or current colectomy
- Severe allergy/intolerance to oral vancomycin
- Patient is expected to die within 3 months from another disease or is expected to be admitted to a palliative care unit
- Failure to achieve clinical cure (as above) by day 10
- More than 2 episodes of C. difficile in the last 5 years.
- 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)
- Known pregnancy or planning to become pregnant during the study period
- Women who are breast feeding
- Administrative:
- Expected transfer to a palliative care unit or non-study hospital;
- No provincial health insurance
- Previously enrolled
- No reliable means of outpatient contact
- Incompetent without healthcare proxy
- Patient stated inability to come to follow up appointments.
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2024
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT04138706
Start Date
November 19 2020
End Date
November 22 2024
Last Update
December 10 2025
Active Locations (12)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
2
Health Sciences Centre - Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
3
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
4
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9