Addressing Personalized Needs in Clostridioides Difficile Infection

NCT04725123 | Completed

• 1 other identifier: BEYOND1
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Clostridioides Difficile Infection

Keywords

Clostridioides difficile; Microbiome; Prediction; Unfavorable outcome

Outcome Measures

Primary Outcomes (1)

• Prediction of unfavorable outcome

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

  40 days

Secondary Outcomes (1)

• Diagnostic PCR reaction in stool

  40 days

Study Arms (1)

Clostridioides difficile infection

EXPERIMENTAL

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

Diagnostic Test: Microbiome analysis

Interventions

Microbiome analysis DIAGNOSTIC_TEST

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

Clostridioides difficile infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (1)

4th Department of Internal Medicine, ATTIKON University General Hospital

Athens, 12462, Greece

Location

Related Publications (1)

• Psarrakis C, Tziolos NR, Matzarakis V, Kumar V, Stylianakis E, Sidiropoulou C, Tasouli E, Iliopoulou K, Samarkos M, Metallidis S, Georgiadou S, Akinosoglou K, Bolanou A, Hatziagelaki E, Kostaki A, Panagopoulos P, Toutouzas K, Milionis H, Adamis G, Poulakou G, Lada M, Skoutelis A, Alexiou Z, Symbardi S, Chrysos G, Netea MG, Giamarellos-Bourboulis EJ. A randomized controlled trial of precision bezlotoxumab treatment for Clostridioides difficile infection. Cell Rep Med. 2026 Jan 20;7(1):102533. doi: 10.1016/j.xcrm.2025.102533. Epub 2026 Jan 2.

  PMID: 41483804 DERIVED

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Evangelos J Giamarellos-Bourboulis, MD, PhD

  National and Kapodistrian University of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 26, 2021
• Study Start: January 26, 2021
• Primary Completion: March 27, 2022
• Study Completion: March 27, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After the end of the study
• Access Criteria: Signed contract for data sharing with the study Sponsot

Locations

GR (1)