Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile

Study Overview
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Brief Summary
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Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing >500,000 infections and >29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other patients.

Official Title
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A Pre-emptive Prevention Bundle for Patients at High Risk for Hospital-onset Clostridioides Difficile

Conditions
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C. Difficile

Intervention / Treatment
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* Other: Arm 1: Routine care
* Other: Arm 2: Preemptive C. difficile infection prevention bundle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab Exclusion Criteria: Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients colonized with toxigenic C. difficile who do not receive the prevention bundle<br>Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive standard of care | Other: Arm 1: Routine care<br>* Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive standard of care.<br>|
| Active Comparator: Patients colonized with toxigenic C. difficile who receive the prevention bundle<br>Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive a preemptive prevention bundle for C. difficile including enhanced room cleaning, C. difficile precautions, pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis. | Other: Arm 2: Preemptive C. difficile infection prevention bundle<br>* Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive a preemptive prevention bundle for C. difficile. The prevention bundle will include enhanced room cleaning, C. difficile precautions (staff entering room must wear gown and gloves and wash hands with soap and water upon exiting the room), pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group | Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Hospital-acquired infection