C. Difficile
Conditions
Keywords
Prevention, Hospital-acquired infection
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.
Interventions
OTHERArm 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.
OTHERArm 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.
Sponsors
Brigham and Women's Hospital
Harvard Pilgrim Health Care Institute
Centers for Disease Control and Prevention
Massachusetts Host-Microbiome Center
Hatch Family Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group | 24 months | Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle |
Countries
United States
Contacts
CONTACTMeghan A Baker, MD, SCD
CONTACTSanjat Kanjilal, MD, MPH
PRINCIPAL_INVESTIGATORMeghan A Baker, MD, SCD
Brigham and Women's Hospital
Outcome results
None listed