Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Arm 1: Routine care

    Other intervention

    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 intervention

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Patients colonized with toxigenic C. difficile who do not receive the prevention bundleActive comparator 1 intervention
Group B: Patients colonized with toxigenic C. difficile who receive the prevention bundleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group

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

Time frame
24 months

Secondary outcomes

Other outcomes

1

Oncology and ICU C. difficile infection rates

Oncology and ICU C. difficile infection incidences before and after implementation of the intervention

Time frame
24 months

Sponsors and contacts

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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

Source ClinicalTrials.gov
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