Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection (TAPER-V)
Clostridium Difficile Infection
About this trial
This is an interventional prevention trial for Clostridium Difficile Infection
Eligibility Criteria
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:
- 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.
Sites / Locations
- Vancouver General HospitalRecruiting
- Sunnybrook Health Science CentreRecruiting
- St. Michael's HospitalRecruiting
- University Health NetworkRecruiting
- McGill University Health Centre (Royal Victoria Hospital)Recruiting
- Jewish General HospitalRecruiting
- Centre hospitalier universitaire de SherbrookeRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Control: Placebo
Intervention: Extended vancomycin regimen
Following a 14-day initial vancomycin treatment (125mg QID x14 days), the participant will receive a placebo for an additional 14 days (twice a day x 7 days, then once a day for 7 days).
Following a 14-day initial vancomycin treatment (125mg QID x14 days), the participant will receive active vancomycin for an additional 14 days (125mg twice a day x 7 days, then 125mg once a day for 7 days).