Status:
RECRUITING
Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
Lead Sponsor:
Riverside University Health System Medical Center
Conditions:
Clostridium Difficile Infection
Vancomycin Resistant Enterococci Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical condition...
Detailed Description
Protocol Synopsis General: Enteral vancomycin has gained attention as a promising strategy for preventing healthcare facility-onset Clostridioides difficile infection (HCFO-CDI) in patients during sy...
Eligibility Criteria
Inclusion
- Must meet all 3 criteria:
- Adults aged 18 years and older.
- Receiving ≥ 72 hours of a systemic antibiotic during index hospitalization.
- Admitted ≥ 72 hours into their index hospitalization.
- And must meet 2 additional of the following high-risk criteria
- Age ≥ 65 years
- Previous residence in long-term care facility
- Previous proton pump inhibitor use (chronic or as needed)
- Inflammatory bowel disease
- Immunocompromised state (HIV/AIDS; transplant recipient; receipt of prednisone 20 mg daily for at least one month, immunosuppressants, or chemotherapy)
- End stage renal disease (ESRD)
- Diabetes mellitus
- Receipt of catecholamines (norepinephrine at a rate of ≥ 5 mcg/min)
- Hospitalized ≤ 30 days prior to the index hospitalization.
- Received systemic antibiotics during that prior hospitalization.
Exclusion
- Pregnant or breastfeeding women
- Currently incarcerated individuals
- Individual or legal representative whose informed consent cannot be obtained
- Subject not expected to survive the ICU stay or subject likely to be considered for palliative or hospice care
- Receiving concurrent treatment with metronidazole for any indication
- One-time empiric use of metronidazole is allowed and does not constitute an exclusion criterion
- Receiving concurrent probiotics
- Allergic reaction or had a contraindication for use of enteral vancomycin
- History of prior CDI within the past 90 days of randomization
- Had suspected active CDI prior to inclusion
- Infection requiring more than 14 21 days of systemic antibiotics during index hospitalization
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT07221370
Start Date
October 21 2024
End Date
December 31 2026
Last Update
November 7 2025
Active Locations (1)
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1
Riverside University Health System
Moreno Valley, California, United States, 92373