Objectives: Bezlotoxumab (BEZ) is a promising tool for preventing recurrence of Clostridioides difficile infection (rCDI). The aim of the study was to emulate, in a real-world setting, the MODIFY trials in a cohort of participants with multiple risk factors for rCDI treated with BEZ in addition to standard of care (SoC) vs. SoC alone. Methods: A multicenter cohort study was conducted including 442 patients with CDI from 2018 to 2022 collected from 18 Italian centers. The main outcome was the 30-days occurrence of rCDI. Secondary outcomes were: (i) all-cause mortality at 30 days (ii) composite outcome (30-day recurrence and/or all-cause death). Results: rCDI at day 30 occurred in 54 (12%): 11 in the BEZ+SoC group and 43 treated with SoC alone (8% vs. 14%, OR=0.58, 95%CI:0.31-1.09, p=0.09). The difference between BEZ+SoC vs. SoC was statistically significant after controlling for confounding factors (aOR=0.40, 95%CI:018-0.88, p=0.02) and even more using the composite outcome (aOR=0.35, 95%CI:0.17-0.73, p=0.005). Conclusion: Our study confirms the efficacy of BEZ+SoC for the prevention of rCDI and death in a real-world setting. BEZ should be routinely considered among participants at high risk of rCDI regardless of age, type of CDI therapy (vancomycin vs. fidaxomicin) and number of risk factors.

Efficacy of bezlotoxumab in preventing recurrence of Clostridioides difficile infection: an Italian multicenter cohort study / Meschiari, Marianna; Cozzi-Lepri, Alessandro; Cervo, Adriana; Granata, Guido; Rogati, Carlotta; Franceschini, Erica; Casolari, Stefania; Tatarelli, Paola; Giacobbe, Daniele Roberto; Bassetti, Matteo; Pinna, Simone Mornese; De Rosa, Francesco Giuseppe; Barchiesi, Francesco; Canovari, Benedetta; Lorusso, Carolina; Russo, Giuseppe; Cenderello, Giovanni; Cascio, Antonio; Petrosillo, Nicola; Mussini, Cristina. - In: INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES. - ISSN 1201-9712. - 131:(2023), pp. 147-154. [10.1016/j.ijid.2023.04.004]

Efficacy of bezlotoxumab in preventing recurrence of Clostridioides difficile infection: an Italian multicenter cohort study

Meschiari, Marianna;Rogati, Carlotta;Franceschini, Erica;Mussini, Cristina
2023

Abstract

Objectives: Bezlotoxumab (BEZ) is a promising tool for preventing recurrence of Clostridioides difficile infection (rCDI). The aim of the study was to emulate, in a real-world setting, the MODIFY trials in a cohort of participants with multiple risk factors for rCDI treated with BEZ in addition to standard of care (SoC) vs. SoC alone. Methods: A multicenter cohort study was conducted including 442 patients with CDI from 2018 to 2022 collected from 18 Italian centers. The main outcome was the 30-days occurrence of rCDI. Secondary outcomes were: (i) all-cause mortality at 30 days (ii) composite outcome (30-day recurrence and/or all-cause death). Results: rCDI at day 30 occurred in 54 (12%): 11 in the BEZ+SoC group and 43 treated with SoC alone (8% vs. 14%, OR=0.58, 95%CI:0.31-1.09, p=0.09). The difference between BEZ+SoC vs. SoC was statistically significant after controlling for confounding factors (aOR=0.40, 95%CI:018-0.88, p=0.02) and even more using the composite outcome (aOR=0.35, 95%CI:0.17-0.73, p=0.005). Conclusion: Our study confirms the efficacy of BEZ+SoC for the prevention of rCDI and death in a real-world setting. BEZ should be routinely considered among participants at high risk of rCDI regardless of age, type of CDI therapy (vancomycin vs. fidaxomicin) and number of risk factors.
2023
131
147
154
Efficacy of bezlotoxumab in preventing recurrence of Clostridioides difficile infection: an Italian multicenter cohort study / Meschiari, Marianna; Cozzi-Lepri, Alessandro; Cervo, Adriana; Granata, Guido; Rogati, Carlotta; Franceschini, Erica; Casolari, Stefania; Tatarelli, Paola; Giacobbe, Daniele Roberto; Bassetti, Matteo; Pinna, Simone Mornese; De Rosa, Francesco Giuseppe; Barchiesi, Francesco; Canovari, Benedetta; Lorusso, Carolina; Russo, Giuseppe; Cenderello, Giovanni; Cascio, Antonio; Petrosillo, Nicola; Mussini, Cristina. - In: INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES. - ISSN 1201-9712. - 131:(2023), pp. 147-154. [10.1016/j.ijid.2023.04.004]
Meschiari, Marianna; Cozzi-Lepri, Alessandro; Cervo, Adriana; Granata, Guido; Rogati, Carlotta; Franceschini, Erica; Casolari, Stefania; Tatarelli, Paola; Giacobbe, Daniele Roberto; Bassetti, Matteo; Pinna, Simone Mornese; De Rosa, Francesco Giuseppe; Barchiesi, Francesco; Canovari, Benedetta; Lorusso, Carolina; Russo, Giuseppe; Cenderello, Giovanni; Cascio, Antonio; Petrosillo, Nicola; Mussini, Cristina
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