drugset / Trial / NCT05304715

Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

NCT05304715

Phase 2 Completed 44 enrolled Hellenic Institute for the Study of Sepsis
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bezlotoxumab Monoclonal antibody 10 mg/kg Intravenous