Addressing Personalized Needs in Clostridioides Difficile Infection

Study Overview
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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.

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

Conditions
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Clostridioides Difficile Infection

Intervention / Treatment
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* Diagnostic Test: Microbiome analysis


Participation Criteria
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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. Exclusion Criteria: • No exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clostridioides difficile infection<br>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<br>* Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridioides difficile, Microbiome, Prediction, Unfavorable outcome