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

Mass General Brigham

Status: Enrolling

Conditions: C. Difficile

Treatments: Other: Arm 2: Preemptive C. difficile infection prevention bundle; Other: Arm 1: Routine care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05389904

2022P000819

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Patients colonized with toxigenic C. difficile who do not receive the prevention bundle

Active Comparator group

Description:

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

Treatment:

Other: Arm 1: Routine care

Patients colonized with toxigenic C. difficile who receive the prevention bundle

Active Comparator group

Description:

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.

Treatment:

Other: Arm 2: Preemptive C. difficile infection prevention bundle