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

NCT05389904 | Recruiting

• 1 other identifier: 2022P000819
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Prevention; Hospital-acquired infection

Outcome Measures

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

  24 months

Other Outcomes (1)

• Oncology and ICU C. difficile infection rates

  24 months

Study Arms (2)

Patients colonized with toxigenic C. difficile who do not receive the prevention bundle

ACTIVE COMPARATOR

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

Other: Arm 1: Routine care

Patients colonized with toxigenic C. difficile who receive the prevention bundle

ACTIVE COMPARATOR

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.

Other: Arm 2: Preemptive C. difficile infection prevention bundle

Interventions

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.

Patients colonized with toxigenic C. difficile who do not receive the prevention bundle

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.

Patients colonized with toxigenic C. difficile who receive the prevention bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Pilgrim Health Care Institute: collaborator
• Centers for Disease Control and Prevention: collaborator
• Massachusetts Host-Microbiome Center: collaborator
• Hatch Family Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meghan A Baker, MD, SCD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan A Baker, MD, SCD

CONTACT

617-732-8881; mbaker1@bwh.harvard.edu

Sanjat Kanjilal, MD, MPH

CONTACT

skanjilal@bwh.harvar.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Hospital Epidemiologist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: July 25, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)