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NCT04725123 Clinical Trial

Addressing Personalized Needs in Clostridioides Difficile Infection

Clostridioides Difficile Infection Clinical Trial

— BEYOND  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04725123
Other study ID # BEYOND1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2021
Est. completion date March 27, 2022

Study information
Verified date December 2023
Source Hellenic Institute for the Study of Sepsis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 153
Est. completion date March 27, 2022
Est. primary completion date March 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Microbiome analysis
Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads

Locations
Country Name City State
Greece 4th Department of Internal Medicine, ATTIKON University General Hospital Athens

Sponsors (1)
Lead Sponsor Collaborator
Hellenic Institute for the Study of Sepsis

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediction of unfavorable outcome Sensitivity of the BEYOND score to predict unfavorable outcome of patients with infection by Clostridioides difficile 40 days
Secondary 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
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