Completed study
Official Study Title
Bezlotoxumab Υielded Οutcomes by addressing personalized Needs in Clostridioides Difficile infection: the BEYOND double-blind randomized clinical trial
Brief Description
Previous data from our group have shown that integrated information from SNPs of the host DNA, IL-8 and the enrichment of the stool microbiome can indicate the patients with infection by Clostridioides difficile (CDI) at risk for unfavorable outcome. This integrated information is forming the BEYOND score. The aim of the BEYOND RCT is to investigate if adjunctive bezlotoxumab treatment to the current standard-of-care may decrease the likelihood of unfavorable outcome for patients who score positive by the BEYOND score.
Details
Status: Completed
Study Type: Interventional (Clinical Trial)
Study phase: II
Study sites: 16 sites in Greece
Target of enrolment: 44 participants
ClinicalTrials.gov Identifier: NCT05304715
EudraCT number: 2021-005473-10
National Organization for Medicines Approval: IS166-21
National Ethics Committee Approval: 178/21
Study Start: April 2022
Condition/Disease studied: Clostridioides Difficile Infection; Stool Microbiome; Organ Dysfunction Syndrome; Clostridium Difficile Infection Recurrence; Mortality
Keywords: Bezlotoxumab
Connect to the BEYOND trial portal