The goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. The ultimate goal is to conduct an appropriately-powered RCT to determine the optimal method for reducing C difficile infection in colonized patients.
In this study, patients will be screened for C. difficile colonization
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Vancomycin capsules
Culturelle capsules
sugar pill manufactured to mimic the vancomycin 125 mg capsule
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.
Feasibility will be assessed using the following parameters: Proportion of eligible participants screened that are randomized within 72 hours of antibiotic exposure (goal ≥ 90%) * Proportion of participants receiving all doses of study medication (goal ≥ 90%) * Proportion of participants with complete follow up at 14 days (goal ≥ 95%)
Time frame: 1 year
Development of C difficile associated diarrhea within 14 days of randomization
Development of C difficile associated diarrhea within 14 days of randomization to one of the treatment arms as defined by the Provincial Infectious Diseases Advisory Committee (PIDAC)
Time frame: 1 year
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sugar pill manufactured to mimic 10 billion unit probiotic capsules.