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

NCT05389904 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-04

No results posted yet for this study

Summary

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.

Conditions

  • C. Difficile

Interventions

OTHER

Arm 1: Routine care

Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive standard of care.

OTHER

Arm 2: Preemptive C. difficile infection prevention bundle

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.

Sponsors & Collaborators

  • Harvard Pilgrim Health Care Institute

    collaborator UNKNOWN

  • Centers for Disease Control and Prevention

    collaborator FED

  • Massachusetts Host-Microbiome Center

    collaborator UNKNOWN

  • Hatch Family Foundation

    collaborator UNKNOWN

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Meghan A Baker, MD, SCD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2025-06-01
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05389904 on ClinicalTrials.gov