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

NCT05389904 — Not applicable, Completed, 261 participants, Brigham and Women's Hospital

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

Registry	NCT05389904
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	261 (Actual)
Sponsor	Brigham and Women's Hospital (Other); collaborators: Harvard Pilgrim Health Care Institute, Centers for Disease Control and Prevention, Massachusetts Host-Microbiome Center, Hatch Family Foundation
Conditions	C. Difficile
Interventions	Arm 1: Routine care, Arm 2: Preemptive C. difficile infection prevention bundle (Other)
Dates	start 2022-07-25, primary completion 2025-06-01, completion 2025-11-14, first posted 2022-05-25, last updated 2026-09-30
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients colonized with toxigenic C. difficile who do not receive the prevention bundle	Active comparator	Other: Arm 1: Routine care	Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive standard of care
Patients colonized with toxigenic C. difficile who receive the prevention bundle	Active comparator	Other: Arm 2: Preemptive C. difficile infection 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.

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.

+Outcome measures

Primary outcomes

Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group [24 months]: Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle

Other outcomes

Oncology and ICU C. difficile infection rates [24 months]: Oncology and ICU C. difficile infection incidences before and after implementation of the intervention

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Brigham and Women's Hospital	Boston, Massachusetts	United States

+Investigators

Meghan A Baker, MD, SCD, Principal investigator, Brigham and Women's Hospital