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Addressing Personalized Needs in Clostridioides Difficile Infection

NCT ID: NCT04725123

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2022-03-27

Brief Summary

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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

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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

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Clostridioides Difficile Infection

Keywords

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Clostridioides difficile Microbiome Prediction Unfavorable outcome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Microbiome analysis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Microbiome analysis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Institute for the Study of Sepsis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evangelos J Giamarellos-Bourboulis, MD, PhD

Role: STUDY_CHAIR

National and Kapodistrian University of Athens

Locations

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4th Department of Internal Medicine, ATTIKON University General Hospital

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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BEYOND1

Identifier Type: -

Identifier Source: org_study_id