Addressing Personalized Needs in Clostridioides Difficile Infection (BEYOND)

  • STATUS
    Recruiting
  • days left to enroll
    83
  • participants needed
    153
  • sponsor
    Hellenic Institute for the Study of Sepsis
Updated on 7 October 2022

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.

Details
Condition Clostridioides Difficile Infection
Treatment Microbiome Analysis
Clinical Study IdentifierNCT04725123
SponsorHellenic Institute for the Study of Sepsis
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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