Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients (Decency-RCT)
Clostridium Difficile Colonization, Clostridium Difficile Diarrhea
About this trial
This is an interventional prevention trial for Clostridium Difficile Colonization
Eligibility Criteria
Inclusion Criteria:
- Adult patients of 18 years of age or older identified as asymptomatic carriers of C. difficile (i.e. not meeting case definition of C. difficile infection, see below)
- Started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection
- Patient must have vitals (heart rate, blood pressure, temperature), estimated creatinine clearance (using the Chronic Kidney Disease Epidemiology equation (CKD-Epi)) and a complete blood count available within 24 hours of enrolment
Exclusion Criteria:
- On a course of systemic antibiotics that had been started more than 72 hours ago (as current evidence suggests that the earlier probiotics are started, the more efficacious they are)
- Patient with C. difficile, i.e. presence of diarrhea (three or more loose or watery stools within 24 hours), or fevers or hypotension from C. difficile infection
Any patients with contra-indications to probiotics or vancomycin:
- Immunosuppressed (primary or acquired immunodeficiency, including AIDS (defined as AIDS defining condition or cluster of differentiation 4 (CD4) nadir of <200/ul), hematologic malignancies, long-term systemic corticosteroid treatment, active treatment with chemotherapeutic agents or biologicals, autoimmune diseases, nephrotic syndrome)
- Structural heart disease (e.g. atrial septal defect, ventricular septal defect)
- Gastroesophageal or compromised gut integrity (e.g. short gut syndrome, intestinal injury or dysfunction, inflammatory bowel diseases including current or past history of Crohn's disease and ulcerative colitis)
- Patients on systemic aminoglycosides, ethacrynic acid, polymixin B, or colistin.
- Prior or current hearing loss
- Female patients with known pregnancy or who are planning to get pregnant, or who are breastfeeding
- Patients with end-stage renal diseases defined as an estimated glomerular filtration rate of <15ml/min, or absence of a current estimated creatinine clearance
- History of an allergic reaction to one of the study drugs, or sensitivity to milk
- Patients started on probiotics or oral vancomycin while in hospital
Sites / Locations
- St. Joseph's Healthcare HamiltonRecruiting
- Hamilton Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Vancomycin & probiotic placebo
Probiotic & vancomycin placebo
Probiotic placebo & vancomycin placebo
Vancomycin 125 mg orally every 12 hours plus probiotic placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.
Culturelle probiotic 20 billion active units orally every 12 hours plus vancomycin placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.
Vancomycin placebo orally every 12 hours and Culturelle placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.