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Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients (Decency-RCT)

Primary Purpose

Clostridium Difficile Colonization, Clostridium Difficile Diarrhea

Status
Recruiting
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Vancomycin
Culturelle
Vancomycin Placebo
Probiotic Placebo
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Colonization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Vancomycin & probiotic placebo

Probiotic & vancomycin placebo

Probiotic placebo & vancomycin placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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%)
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)

Secondary Outcome Measures

Full Information

First Posted
January 20, 2020
Last Updated
September 20, 2023
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04246151
Brief Title
Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients
Acronym
Decency-RCT
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Colonization, Clostridium Difficile Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to receive either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Blinding will be done in a double-blind fashion. The patients, their caregiver, and the investigator will be blinded to the study treatment.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin & probiotic placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Probiotic & vancomycin placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Probiotic placebo & vancomycin placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
JAMP-vancomycin
Intervention Description
Vancomycin capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Culturelle
Other Intervention Name(s)
Lactobacillus rhamnosus GG
Intervention Description
Culturelle capsules
Intervention Type
Drug
Intervention Name(s)
Vancomycin Placebo
Other Intervention Name(s)
Placebo for Vancomycin
Intervention Description
sugar pill manufactured to mimic the vancomycin 125 mg capsule
Intervention Type
Drug
Intervention Name(s)
Probiotic Placebo
Other Intervention Name(s)
Placebo for probiotic
Intervention Description
sugar pill manufactured to mimic 10 billion unit probiotic capsules.
Primary Outcome Measure Information:
Title
Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.
Description
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
Title
Development of C difficile associated diarrhea within 14 days of randomization
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominik Mertz, MD
Phone
905-525-9140
Ext
43952
Email
mertz@hhsc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jodi Gilchrist, MSc
Phone
905-522-1155
Ext
33454
Email
jgilchri@stjoes.ca
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Smieja, MD/PhD
Phone
905-521-6021
Email
smiejam@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Jodi Gilchrist, MSc
Phone
905-522-1155
Ext
33454
Email
jgilchri@stjoes.ca
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Mertz, MD
Phone
905-525-9140
Ext
43952
Email
Mertz@hhsc.ca
First Name & Middle Initial & Last Name & Degree
Jodi Gilchrist, MSc
Phone
905-522-1155
Ext
33454
Email
jgilchri@stjoes.ca
First Name & Middle Initial & Last Name & Degree
Mark Loeb, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with researchers that are not directly involved in this study. Overall data will be shared in the context of peer reviewed journal publications or scientific presentations.

Learn more about this trial

Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients

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