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

Cell reports. Medicine

Authors: Christos Psarrakis, Nikolaos-Renatos Tziolos, Vicky Matzarakis, Vinod Kumar, Emmanouil Stylianakis, Chrysanthi Sidiropoulou, Elisavet Tasouli, Konstantina Iliopoulou, Michael Samarkos, Symeon Metallidis, Sarah Georgiadou, Karolina Akinosoglou, Amalia Bolanou, Erifli Hatziagelaki, Alina Kostaki, Periklis Panagopoulos, Konstantinos Toutouzas, Haralarampos Milionis, Georgios Adamis, Garyfallia Poulakou, Malvina Lada, Athanasios Skoutelis, Zoi Alexiou, Styliani Symbardi, George Chrysos, Mihai G Netea, Evangelos J Giamarellos-Bourboulis

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.

Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.

PMID: 41483804

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