Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT05389904

Conditions

C. Difficile

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arm 1: Routine care

Arm 2: Preemptive C. difficile infection prevention bundle

Study Details

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.

Conditions

C. Difficile

Study ID

NCT05389904

Start date

Jul 25, 2022

Status verified date

Jul, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Jun 1, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Arm 1: Routine care

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

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.

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 and Locations

Central contacts

Sanjat Kanjilal, MD, MPH

skanjilal@bwh.harvar.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Mar 4, 2026

Last verified

Jul, 2025

Keywords

  • Prevention
  • Hospital-acquired infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-03-04.