Status:
TERMINATED
Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.
Lead Sponsor:
Michael E Villarreal, MD
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Clostridia Difficile Colitis
Clostridium; Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A new medication, Bezlotoxumab, has been approved for treatment of recurrent Clostridium difficile diarrhea by the U.S. Food and Drug Administration. The way this new medication works, is by binding t...
Detailed Description
Study Design This will be an interventional prospective, randomized, double-blinded controlled trial performed at a single center. Prospective data will be collected of all consenting patients with a ...
Eligibility Criteria
Inclusion
- \> 18 years old, diagnosed C diff colitis requiring surgical intervention
Exclusion
- CHF previously diagnosed, pregnancy, prisoners/ incarcerated, previous administration of IVIG within 30-days of randomization
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03756454
Start Date
August 19 2019
End Date
May 23 2022
Last Update
May 12 2023
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210