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

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

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.

Study Overview

• Status: Recruiting
• Conditions: C. Difficile
• Intervention / Treatment: Other: Arm 1: Routine care; Other: Arm 2: Preemptive C. difficile infection prevention bundle

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan A Baker, MD, SCD; Phone Number: 617-732-8881; Email: mbaker1@bwh.harvard.edu
• Study Contact Backup: Name: Sanjat Kanjilal, MD, MPH; Email: skanjilal@bwh.harvar.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Meghan A Baker, MD, SCD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncology and ICU C. difficile infection rates	Oncology and ICU C. difficile infection incidences before and after implementation of the intervention	24 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Centers for Disease Control and Prevention; Harvard Pilgrim Health Care Institute; Massachusetts Host-Microbiome Center; Hatch Family Foundation
• Investigators: Principal Investigator: Meghan A Baker, MD, SCD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): June 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Hospital-acquired infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Cross Infection
• Other Study ID Numbers: 2022P000819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No