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

Conditions

• C. Difficile

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Arm 1: Routine care — OTHER
  Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive standard of care.
• Arm 2: Preemptive C. difficile infection prevention bundle — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jul 25, 2022

Status verified

Jul 2025

Primary completion

Jun 1, 2025

Completion

Aug 31, 2026

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Patients colonized with toxigenic C. difficile who do not receive the prevention bundle
  Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive standard of care
• Active Comparator: Patients colonized with toxigenic C. difficile who receive the prevention bundle
  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.

Primary Outcome Measure

Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group [ Time Frame: 24 months ]

Central Contacts

• Meghan A Baker, MD, SCD
  617-732-8881
  [email protected]
• Sanjat Kanjilal, MD, MPH
  [email protected]

Locations (1)

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