Addressing Personalized Needs in Clostridioides Difficile Infection (BEYOND)

Hellenic Institute for the Study of Sepsis

Status: Completed

Conditions: Clostridioides Difficile Infection

Treatments: Diagnostic Test: Microbiome analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT04725123

BEYOND1

Details and patient eligibility

About

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

Full 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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 1 patient group

Clostridioides difficile infection

Experimental group

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

Treatment:

Diagnostic Test: Microbiome analysis