Status:
COMPLETED
Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Clostridium Difficile Infection
Clostridium Difficile Infection Recurrence
Eligibility:
All Genders
18+ years
Brief Summary
This is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard C. difficile infection (CDI) treatment compared to standard CDI treatment alone in patients with CDI...
Detailed Description
This specialty clinic is a unique practice setting where patients with ≥1 recurrent CDI and/or refractory disease are referred. The study will represent real-world data on the clinical use of bezlotox...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Cases):
- Age 18 years and older
- Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
- Received bezlotoxumab in addition to standard CDI treatment
- Inclusion Criteria (Controls):
- Age 18 years and older
- Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
- Received only standard CDI treatment
- Exclusion Criteria:
- Diarrhea due to causes other than C. difficile
- Incomplete documentation in the electronic medical record
Exclusion
Key Trial Info
Start Date :
February 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 22 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04317963
Start Date
February 12 2020
End Date
February 22 2023
Last Update
February 28 2023
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153