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| Name | Class |
|---|---|
| Harvard Pilgrim Health Care Institute | UNKNOWN |
| Centers for Disease Control and Prevention | FED |
| Massachusetts Host-Microbiome Center | UNKNOWN |
| Hatch Family Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meghan A Baker, MD, SCD | Contact | 617-732-8881 | mbaker1@bwh.harvard.edu | |
| Sanjat Kanjilal, MD, MPH | Contact | skanjilal@bwh.harvar.edu |
| Name | Affiliation | Role |
|---|---|---|
| Meghan A Baker, MD, SCD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| UNKNOWN |
Randomized controlled trial
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| 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. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |