Clinical trial NCT04246151: Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients
Official title: Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients (Decency-RCT): A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Clostridium Difficile Colonization
Clostridium Difficile Diarrhea
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: In this study, patients will be screened for C. 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

Primary outcomes:
measure: Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.
timeFrame: 1 year
measure: Development of C difficile associated diarrhea within 14 days of randomization
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
References: