Addressing Personalized Needs in Clostridioides Difficile Infection

Not Applicable

Completed

• Conditions: Clostridioides Difficile Infection
• Interventions: Diagnostic Test: Microbiome analysis

• Registration Number: NCT04725123
• Lead Sponsor: Hellenic Institute for the Study of Sepsis

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.

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study Start: 2021-01-26
• Study First Posted: 2021-01-26
• Primary Completion: 2022-03-27
• Study Completion: 2022-03-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clostridioides difficile infection	Microbiome analysis	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

Primary Outcome Measures

Name	Time	Method
Prediction of unfavorable outcome	40 days	Sensitivity of the BEYOND score to predict unfavorable outcome of patients with infection by Clostridioides difficile

Secondary Outcome Measures

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

Trial Locations

Locations (1)

4th Department of Internal Medicine, ATTIKON University General Hospital; 🇬🇷 Athens, Greece