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

ConditionC. Difficile
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab

Disqualifiers

Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units

Trial design

Treatments tested in this trial

  • Arm 1: Routine care
  • Arm 2: Preemptive C. difficile infection prevention bundle

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Brigham and Women's Hospital

Lead sponsor

Harvard Pilgrim Health Care Institute

Collaborator

Centers for Disease Control and Prevention

Collaborator

Massachusetts Host-Microbiome Center

Collaborator

Hatch Family Foundation

Collaborator