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

C. Difficile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389904
• Other study ID #: 2022P000819
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: August 2026

Study information

• Verified date: September 2022
• Source: Brigham and Women's Hospital
• Contact: Meghan A Baker, MD, SCD
• Phone: 617-732-8881
• Email: mbaker1[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C. Difficile

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Centers for Disease Control and Prevention, Harvard Pilgrim Health Care Institute, Hatch Family Foundation, Massachusetts Host-Microbiome Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oncology and ICU C. difficile infection rates	Oncology and ICU C. difficile infection incidences before and after implementation of the intervention	24 months
Primary	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