Addressing Personalized Needs in Clostridioides Difficile Infection (BEYOND)

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

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

Study Overview

• Status: Completed
• Conditions: Clostridioides Difficile Infection
• Intervention / Treatment: Diagnostic test: Microbiome analysis

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evangelos J Giamarellos-Bourboulis, MD, PhD; Phone Number: 994 00302105831000; Email: egiamarel@med.uoa.gr
• Study Contact Backup: Name: Asimina Safarika, MD, PhD; Phone Number: 925 00302105831000; Email: asafarika@yahoo.gr

Study Locations

• Greece
  • Athens, Greece, 12462
    • 4th Department of Internal Medicine, ATTIKON University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age more than or equal to 18 years
• Both genders
• Diarrhea defined as at least 3 episodes of unformed stools in the last 24hours according to the Bristol stool chart
• Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.

Exclusion Criteria:

• No exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clostridioides difficile infection; Stool of patients with Clostridioides difficile infection that will be subject to microbiome analysis. Comparisons will be done between patients with favorable and unfavorable outcome	Diagnostic test: Microbiome analysis; Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of unfavorable outcome	Sensitivity of the BEYOND score to predict unfavorable outcome of patients with infection by Clostridioides difficile	40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic PCR reaction in stool	Development of one RT-PCR reaction informing of the predominance of bacterial generum causing low microbiome diversity associated with the unfavorable outcome of CDI.	40 days

Collaborators and Investigators

• Sponsor: Hellenic Institute for the Study of Sepsis
• Investigators: Study Chair: Evangelos J Giamarellos-Bourboulis, MD, PhD, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): March 27, 2022
• Study Completion (Actual): March 27, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Prediction; Clostridioides difficile; Unfavorable outcome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections
• Other Study ID Numbers: BEYOND1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared with other investigators after the end of the study.
• IPD Sharing Time Frame: After the end of the study
• IPD Sharing Access Criteria: Signed contract for data sharing with the study Sponsot
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No