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Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

NCT05304715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-03-04

Study results available
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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.

Conditions

  • Clostridioides Difficile Infection
  • Stool Microbiome
  • Organ Dysfunction Syndrome
  • Clostridioides Difficile Infection Recurrence
  • Mortality

Interventions

DRUG

Bezlotoxumab

Single intravenous infusion of bezlotoxumab

DRUG

Normal saline 0.9% or 5% dextrose water

Single intravenous infusion - Placebo arm

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

  • Evangelos J Giamarellos-Bourboulis, MD, PhD · Hellenic Sepsis Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2023-06-04
Completion
2023-06-04

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05304715 on ClinicalTrials.gov