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

Not Applicable
Recruiting
Conditions
C. Difficile
Registration Number
NCT05389904
Lead Sponsor
Brigham and Women's Hospital
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group24 months

Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

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