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Completed

NCT Number: NCT04725123

Addressing Personalized Needs in Clostridioides Difficile Infection

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

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Key information

Conditions

Clostridioides Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

4th Department of Internal Medicine, ATTIKON University General Hospital

Athens, 12462, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiome analysis

Diagnostic Test

Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads

Primary outcomes

  1. Prediction of unfavorable outcome

    Time frame: 40 days

    Sensitivity of the BEYOND score to predict unfavorable outcome of patients with infection by Clostridioides difficile

Secondary outcomes

  1. Diagnostic PCR reaction in stool

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hellenic Institute for the Study of Sepsis

Other

Registry information

Official study title

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

Acronym: BEYOND

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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