CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Bezlotoxumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05304715
NCT05304715Phase 2Completed
CompareCT.gov

Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection: The BEYOND Double-Blind Randomized Clinical Trial

Hellenic Institute for the Study of Sepsis·interventional·Posted Mar 31, 2022·Updated Mar 4, 2026

In Brief

A Phase 2 clinical trial evaluating Bezlotoxumab and Normal saline 0.9% or 5% dextrose water for Clostridioides Difficile Infection and 4 related conditions. Completed, enrolled 44 participants across 11 sites.

Detailed Summary

Previous data have shown that integrated information from single nucleotide polymorphisms (SNPs) of the host DNA, interleukin 8 (IL-8) and the enrichment of the stool microbiome can indicate the patients with infection by Clostridioides difficile (CDI) who are at risk for unfavorable outcome. This integrated information is forming the BEYOND score. The aim of the BEYOND randomized clinical trial (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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
CountriesGreece
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 31, 2022
Enrollment StartApr 13, 2022
Primary CompletionJun 4, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.3 years ago

Interventions

Bezlotoxumabdrug

Single intravenous infusion of bezlotoxumab

Normal saline 0.9% or 5% dextrose waterdrug

Single intravenous infusion - Placebo arm