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Addressing Personalized Needs in Clostridioides Difficile Infection (BEYOND)

Primary Purpose

Clostridioides Difficile Infection

Status

Recruiting

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Microbiome analysis

About this trial

This is an interventional diagnostic trial for Clostridioides Difficile Infection focused on measuring Clostridioides difficile, Microbiome, Prediction, Unfavorable outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

4th Department of Internal Medicine, ATTIKON University General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clostridioides difficile infection

Arm Description

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

Outcomes

Primary Outcome Measures

Prediction of unfavorable outcome

Sensitivity of the BEYOND score to predict unfavorable outcome of patients with infection by Clostridioides difficile

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04725123

First Posted

January 25, 2021

Last Updated

September 2, 2022

Sponsor

Hellenic Institute for the Study of Sepsis

1. Study Identification

Unique Protocol Identification Number

NCT04725123

Brief Title

Addressing Personalized Needs in Clostridioides Difficile Infection

Acronym

BEYOND

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hellenic Institute for the Study of Sepsis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridioides Difficile Infection

Keywords

Clostridioides difficile, Microbiome, Prediction, Unfavorable outcome

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

153 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clostridioides difficile infection

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Microbiome analysis

Intervention Description

Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads

Primary Outcome Measure Information:

Title

Prediction of unfavorable outcome

Description

Sensitivity of the BEYOND score to predict unfavorable outcome of patients with infection by Clostridioides difficile

Time Frame

40 days

Secondary Outcome Measure Information:

Title

Diagnostic PCR reaction in stool

Description

Development of one RT-PCR reaction informing of the predominance of bacterial generum causing low microbiome diversity associated with the unfavorable outcome of CDI.

Time Frame

40 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evangelos J Giamarellos-Bourboulis, MD, PhD

Phone

00302105831000

Ext

994

egiamarel@med.uoa.gr

First Name & Middle Initial & Last Name or Official Title & Degree

Asimina Safarika, MD, PhD

Phone

00302105831000

Ext

925

asafarika@yahoo.gr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evangelos J Giamarellos-Bourboulis, MD, PhD

Organizational Affiliation

National and Kapodistrian University of Athens

Official's Role

Study Chair

Facility Information:

Facility Name

4th Department of Internal Medicine, ATTIKON University General Hospital

City

Athens

ZIP/Postal Code

12462

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evangelos J Giamarellos-Bourboulis, MD, PhD

Phone

00302105831000

Ext

994

egiamarel@med.uoa.gr

First Name & Middle Initial & Last Name & Degree

Georgia Damoraki, MD, PhD

Phone

00302105831000

Ext

994

gdamoraki@gmail.com

First Name & Middle Initial & Last Name & Degree

Evangelos J Giamarellos-Bourboulis, MD, PhD

First Name & Middle Initial & Last Name & Degree

Asimina Safarika, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Addressing Personalized Needs in Clostridioides Difficile Infection

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