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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Clostridioides Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections

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