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Addressing Personalized Needs in Clostridioides Difficile Infection — BEYOND  

Clostridioides Difficile Infection Clinical Trial

Official title:
Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection: Study Phase 1

Clinical Trial Summary

BEYOND is aiming to demonstrate how by enrichment of the available SPECIFY score, patients at great likelihood for CDI with unfavorable outcome are early detected

Clinical Trial Description

In a previous project, following GWAS analysis of the DNA and measurement of serum biomarkers coming from 134 patients a prediction score named SPECIFY was developed. The SPECIFY score comprises four elements: low hemoglobin, increased urea, increased IL-8 and carriage of G alleles of rs2091172. The score has 80% positive predictive value and 95.8% specificity for the early detection of unfavorable outcome but the sensitivity is low. Unfavorable outcome is defined as any of: presentation or progression into severe CDI, relapse; and death. Stool samples of day 1 before start of therapy of the patients are stored refrigerated. Microbiome analysis will be done aiming to the integration of the Shannon diversity index to the already developed score in order to improve sensitivity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04725123
Study type Interventional
Source Hellenic Institute for the Study of Sepsis
Contact
Status Completed
Phase N/A
Start date January 26, 2021
Completion date March 27, 2022
View Details
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