NCT04725123

Addressing Personalized Needs in Clostridioides Difficile Infection

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Hellenic Institute for the Study of Sepsis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Clostridioides Difficile Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Microbiome analysis	Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads

Timeline

• Start date: 2021-01-26
• Primary completion: 2022-03-27
• Completion: 2022-03-27
• First posted: 2021-01-26
• Last updated: 2023-12-12

Locations

1 site across 1 country: Greece