Evidence map›Paper›PMID 41483804›Full record

Trial reportCell reports. Medicine2026

A randomized controlled trial of precision bezlotoxumab treatment for Clostridioides difficile infection.

Christos Psarrakis, Nikolaos-Renatos Tziolos, Vicky Matzarakis, Vinod Kumar, Emmanouil Stylianakis, Chrysanthi Sidiropoulou, Elisavet Tasouli, Konstantina Iliopoulou, Michael Samarkos, Symeon Metallidis and 17 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cell reports. Medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02573571 completednot on this map

Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy

TypeobservationalSponsorUniversity of AthensRan2015 to 2017Enrolled150ConditionsBiologic Markers, Clinical MarkersArmsDevelopment of biomarkers
NCT04725123 nacompletednot on this map

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

TypeinterventionalSponsorHellenic Institute for the Study of SepsisRan2021 to 2022Enrolled153ConditionsClostridioides Difficile InfectionArmsMicrobiome analysis
NCT05304715 phase2completednot on this map

Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection: The BEYOND Double-Blind Randomized Clinical Trial

TypeinterventionalSponsorHellenic Institute for the Study of SepsisRan2022 to 2023Enrolled44ConditionsClostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection RecurrenceArmsBezlotoxumab, Normal saline 0.9% or 5% dextrose water
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Christos Psarrakis4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
Nikolaos-Renatos Tziolos4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
Vicky MatzarakisDepartment of Internal Medicine and Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.
Vinod KumarDepartment of Internal Medicine and Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.
Emmanouil StylianakisHellenic Institute for the Study of Sepsis, Athens, Greece.
Chrysanthi Sidiropoulou2(nd) Department of Internal Medicine, TZANEIO General Hospital, Piraeus, Greece.
Elisavet Tasouli1(st) Department of Internal Medicine, THRIASIO General Hospital, Eleusis, Greece.
Konstantina Iliopoulou2(nd) Department of Internal Medicine, THRIASIO General Hospital, Eleusis, Greece.
Michael Samarkos1(st) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
Symeon Metallidis1(st) Department of Internal Medicine, Aristotle University of Thessaloniki, Medical School, Thessaloniki, Greece.
Sarah GeorgiadouDepartment of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, Full Member of the European Reference Network on Hepatological Diseases (ERN RARE-LIVER), General University Hospital of Larissa, Larissa, Greece.
Karolina AkinosoglouDepartment of Internal Medicine, University of Patras, Rion, Greece.
Amalia BolanouHellenic Institute for the Study of Sepsis, Athens, Greece.
Erifli Hatziagelaki2(nd) Department of Propaedeutic Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
Alina KostakiHellenic Institute for the Study of Sepsis, Athens, Greece.
Periklis Panagopoulos2(nd) Department of Internal Medicine, Democritus University of Thrace, Medical School, Medical School, Alexandroupolis, Greece.
Konstantinos Toutouzas1st University Department of Propaedeutic Surgery, IPPOKRATEION General Hospital, Athens, Greece.
Haralarampos Milionis1(st) Department of Internal Medicine, University of Ioannina, Medical School, Ioannina, Greece.
Georgios Adamis1(st) Department of Internal Medicine, G. GENNIMATAS General Hospital of Athens, Athens, Greece.
Garyfallia Poulakou3(rd) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
Malvina Lada2(nd) Department of Internal Medicine, Sismanoglion General Hospital, Athens, Greece.
Athanasios Skoutelis5(th) Department of Internal Medicine and Infectious Disease Unit, Evangelismos General Hospital, Athens, Greece.
Zoi Alexiou2(nd) Department of Internal Medicine, THRIASIO General Hospital, Eleusis, Greece.
Styliani Symbardi1(st) Department of Internal Medicine, THRIASIO General Hospital, Eleusis, Greece.
George Chrysos2(nd) Department of Internal Medicine, TZANEIO General Hospital, Piraeus, Greece.
Mihai G NeteaDepartment of Internal Medicine and Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands; Department of Immunology and Metabolism, Life and Medical Sciences Institute (LIMES), University of Bonn, Bonn, Germany.
Evangelos J Giamarellos-Bourboulis4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece; Hellenic Institute for the Study of Sepsis, Athens, Greece. Electronic address: egiamarel@med.uoa.gr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Early risk recognition for organ dysfunction and death by Clostridioides difficile infection (CDI) is an unmet need. A prediction score is developed in the BEYOND study (ClinicalTrials.gov; NCT02573571, NCT04725123, and NCT05304715). At the first stage, using 153 patients and 150 comparators, the BEYOND score was developed integrating hemoglobin; blood urea; blood interleukin-8; carriage of G alleles of rs2091172; and presence of Terrisporobacter glycolicus, Enterococcus avium, and Anaerovorax odorimutans in the stool. The score had 84.6% sensitivity and 95.8% specificity for unfavorable outcomes. At the second stage, a double-blind randomized controlled trial was performed, and 44 patients at high-risk by BEYOND score were treated with standard-of-care plus Bezlotoxumab or placebo. The primary endpoint was the incidence of organ dysfunction, CDI relapse, and/or death. This endpoint was met in 72.7% of patients in the placebo arm and 31.8% in the Bezlotoxumab arm (p = 0.015). Results suggest that BEYOND score can detect early risk in patients with CDI.

Indexed as

Antibodies, MonoclonalBroadly Neutralizing AntibodiesClostridioides difficileClostridium InfectionsAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, MonoclonalbezlotoxumabBroadly Neutralizing AntibodiesbezlotoxumabClostridioides difficilemicrobiomesingle-nucleotide polymorphisms

Identifiers

PMID41483804
PMCPMC12866142

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.