Trials Sponsors Conditions Drugs Pricing

Conditions

Biologic Markers Clinical Markers

Keywords

single nucleotide polymorphismscytokinesmicrobiome

Outcome Measures

Primary Outcomes (1)

Definition of prognostic biomarker
Patients with positive score and unfavorable outcome. Unfavorable outcome is defined as at least one of the following: a) number of patients with severe infection at disease onset; b) number of patients who progress into severe infection; c) number of patients with disease recurrence; and d) number of patients who die
12 months

Study Arms (1)

Clostridium difficile infection

Patients with Clostridium difficile-associated diarrhea for development of biomarkers

Other: Development of biomarkers

Interventions

Development of biomarkersOther

Blood sampling

Also known as: Single nucleotide polymorphisms, Serum cytokines

Clostridium difficile infection

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients with Clostridium difficile-associated diarrhea

You may qualify if:

Age equal to or more than 18 years

Sponsors & Collaborators

Hellenic Sepsis Study Group
Othercollaborator
University of Athens
Otherlead

Study Sites (12)

5th Department of Internal Medicine, Evangelismos Athens General Hospital

Athens, 10676, Greece

1st Department of Internal Medicine, "G.Gennimatas" General hospital

Athens, 11527, Greece

1st Department of Internal Medicine, Laikon General Hospital

Athens, 11527, Greece

3rd Department of Internal Medicine, Sotiria General Hospital

Athens, 11527, Greece

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, 12462, Greece

2nd Department of Internal Medicine, Sismanogleion General Hospital

Athens, 15126, Greece

1st Department of Internal Medicine, Thriassio General Hospital

Related Publications (3)

Rao K, Erb-Downward JR, Walk ST, Micic D, Falkowski N, Santhosh K, Mogle JA, Ring C, Young VB, Huffnagle GB, Aronoff DM. The systemic inflammatory response to Clostridium difficile infection. PLoS One. 2014 Mar 18;9(3):e92578. doi: 10.1371/journal.pone.0092578. eCollection 2014.
PMID: 24643077BACKGROUND
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

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for human DNA extraction and human stool for whole bacterial DNA extraction. Sampling is done on the first day and on disease recurrence

MeSH Terms

Interventions

Polymorphism, Single Nucleotide

Intervention Hierarchy (Ancestors)

Polymorphism, GeneticGenetic VariationGenetic Phenomena

Study Officials

Athanasios Skoutelis, MD
Evangelismos Athens General Hospital
PRINCIPAL INVESTIGATOR
Evangelos J Giamarellos-Bourboulis, MD, PhD
Attikon Hospital
STUDY CHAIR
George Chrysos, MD, PhD
Tzaneion Piraeus General Hospital
PRINCIPAL INVESTIGATOR
Styliani Symbardi, MD, PhD
Thriassio Elefsis General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

150 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor of Internal Medicine

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 12, 2015

Study Start

October 2015

Actual (reported)

Personalized Needs in Clostridium Difficile Infections

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Clostridium difficile infection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (3)

Biospecimen

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Clostridium difficile infection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (3)

Biospecimen

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations