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

Clostridium Difficile Diarrhea Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04246151
• Other study ID #: DECENCY-RCT
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Hamilton Health Sciences Corporation
• Contact: Dominik Mertz, MD
• Phone: 905-525-9140
• Email: mertz[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this study, patients will be screened for C. difficile colonization

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Colonization
• Clostridium Difficile Diarrhea
• Clostridium Infections
• Diarrhea

Intervention

Drug:
• Vancomycin
Vancomycin capsules

Dietary Supplement:
• Culturelle
Culturelle capsules

Drug:
• Vancomycin Placebo
sugar pill manufactured to mimic the vancomycin 125 mg capsule
• Probiotic Placebo
sugar pill manufactured to mimic 10 billion unit probiotic capsules.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%)	1 year
Primary	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)	1 year