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

NCT ID: NCT05389904

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2026-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Arm 1: Routine care

Intervention Type: OTHER

Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive standard of care.

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.

Group Type: ACTIVE_COMPARATOR

Arm 2: Preemptive C. difficile infection prevention bundle

Intervention Type: 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.

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.

Intervention Type: 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, 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard Pilgrim Health Care Institute

UNKNOWN

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Massachusetts Host-Microbiome Center

UNKNOWN

Sponsor Role: collaborator

Hatch Family Foundation

UNKNOWN

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Meghan A. Baker, M.D

Associate Hospital Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meghan A Baker, MD, SCD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meghan A Baker, MD, SCD

Role: CONTACT

mbaker1@bwh.harvard.edu

617-732-8881

Sanjat Kanjilal, MD, MPH

Role: CONTACT

skanjilal@bwh.harvar.edu

Facility Contacts

Meghan A Baker, MD, SCD

Role: primary

Other Identifiers

2022P000819

Identifier Type: -

Identifier Source: org_study_id