Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective Study from Aichi Prefecture, Japan
<b>Background/Objectives:</b> <i>Clostridioides difficile</i> infection (CDI) poses a significant healthcare challenge, with recurrence rates reaching 30%, leading to substantial morbidity and costs. Fidaxomicin (FDX) and bezlotoxumab (BEZ) have shown potential in reducing re...
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| Format: | Article |
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MDPI AG
2025-02-01
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| Series: | Antibiotics |
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| Online Access: | https://www.mdpi.com/2079-6382/14/3/228 |
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| author | Jun Hirai Nobuaki Mori Yuki Hanai Nobuhiro Asai Mao Hagihara Hiroshige Mikamo |
| author_facet | Jun Hirai Nobuaki Mori Yuki Hanai Nobuhiro Asai Mao Hagihara Hiroshige Mikamo |
| author_sort | Jun Hirai |
| collection | DOAJ |
| description | <b>Background/Objectives:</b> <i>Clostridioides difficile</i> infection (CDI) poses a significant healthcare challenge, with recurrence rates reaching 30%, leading to substantial morbidity and costs. Fidaxomicin (FDX) and bezlotoxumab (BEZ) have shown potential in reducing recurrence; however, real-world data on the efficacy of their combination in high-risk CDI patients remain limited. This study aimed to evaluate the efficacy and safety of FDX + BEZ compared with FDX alone in CDI patients with recurrence risk factors. <b>Methods:</b> CDI patients with ≥two recurrence risk factors treated with FDX alone or FDX + BEZ were analyzed. Sixteen factors were evaluated as risk factors for recurrent CDI based on findings from previous studies. Patients with FDX treatment duration <10 days or other CDI treatment prior to FDX were excluded. Outcomes included recurrence within 2 months, global and clinical cure rates, and adverse events. Univariate and multivariate analyses were performed to evaluate efficacy. <b>Results:</b> Among 82 patients, the FDX + BEZ group (<i>n</i> = 30) demonstrated significantly higher global (86.7% vs. 65.4%; <i>p</i> < 0.05) and clinical cure rates (90.0% vs. 69.2%; <i>p</i> < 0.05) compared with the FDX-alone group (<i>n</i> = 52), despite more severe cases in the combination group. Recurrence rates were non-significantly lower in the FDX + BEZ group (3.3% vs. 11.5%). Combination therapy also accelerated diarrhea resolution without additional adverse events. Multivariate analysis identified FDX + BEZ as significantly associated with improved clinical cure (adjusted odds ratio 4.167; 95% CI: 1.029–16.885). <b>Conclusions:</b> FDX + BEZ therapy offers superior efficacy and safety in CDI patients with recurrence risk factors, presenting a promising strategy for optimizing CDI management. |
| format | Article |
| id | doaj-art-9fc60bc49bce4e4fa51cfd96812bb88d |
| institution | OA Journals |
| issn | 2079-6382 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Antibiotics |
| spelling | doaj-art-9fc60bc49bce4e4fa51cfd96812bb88d2025-08-20T02:11:25ZengMDPI AGAntibiotics2079-63822025-02-0114322810.3390/antibiotics14030228Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective Study from Aichi Prefecture, JapanJun Hirai0Nobuaki Mori1Yuki Hanai2Nobuhiro Asai3Mao Hagihara4Hiroshige Mikamo5Department of Clinical Infectious Diseases, Aichi Medical University Hospital, Aichi 480-1195, JapanDepartment of Clinical Infectious Diseases, Aichi Medical University Hospital, Aichi 480-1195, JapanDepartment of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Toho University, Chiba 274-8510, JapanDepartment of Clinical Infectious Diseases, Aichi Medical University Hospital, Aichi 480-1195, JapanDepartment of Molecular Epidemiology and Biomedical Sciences, Aichi Medical University Hospital, Aichi 480-1195, JapanDepartment of Clinical Infectious Diseases, Aichi Medical University Hospital, Aichi 480-1195, Japan<b>Background/Objectives:</b> <i>Clostridioides difficile</i> infection (CDI) poses a significant healthcare challenge, with recurrence rates reaching 30%, leading to substantial morbidity and costs. Fidaxomicin (FDX) and bezlotoxumab (BEZ) have shown potential in reducing recurrence; however, real-world data on the efficacy of their combination in high-risk CDI patients remain limited. This study aimed to evaluate the efficacy and safety of FDX + BEZ compared with FDX alone in CDI patients with recurrence risk factors. <b>Methods:</b> CDI patients with ≥two recurrence risk factors treated with FDX alone or FDX + BEZ were analyzed. Sixteen factors were evaluated as risk factors for recurrent CDI based on findings from previous studies. Patients with FDX treatment duration <10 days or other CDI treatment prior to FDX were excluded. Outcomes included recurrence within 2 months, global and clinical cure rates, and adverse events. Univariate and multivariate analyses were performed to evaluate efficacy. <b>Results:</b> Among 82 patients, the FDX + BEZ group (<i>n</i> = 30) demonstrated significantly higher global (86.7% vs. 65.4%; <i>p</i> < 0.05) and clinical cure rates (90.0% vs. 69.2%; <i>p</i> < 0.05) compared with the FDX-alone group (<i>n</i> = 52), despite more severe cases in the combination group. Recurrence rates were non-significantly lower in the FDX + BEZ group (3.3% vs. 11.5%). Combination therapy also accelerated diarrhea resolution without additional adverse events. Multivariate analysis identified FDX + BEZ as significantly associated with improved clinical cure (adjusted odds ratio 4.167; 95% CI: 1.029–16.885). <b>Conclusions:</b> FDX + BEZ therapy offers superior efficacy and safety in CDI patients with recurrence risk factors, presenting a promising strategy for optimizing CDI management.https://www.mdpi.com/2079-6382/14/3/228bezlotoxumabfidaxomicincombination therapy<i>Clostridioides difficile</i>recurrencesevere diarrhea |
| spellingShingle | Jun Hirai Nobuaki Mori Yuki Hanai Nobuhiro Asai Mao Hagihara Hiroshige Mikamo Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective Study from Aichi Prefecture, Japan Antibiotics bezlotoxumab fidaxomicin combination therapy <i>Clostridioides difficile</i> recurrence severe diarrhea |
| title | Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective Study from Aichi Prefecture, Japan |
| title_full | Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective Study from Aichi Prefecture, Japan |
| title_fullStr | Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective Study from Aichi Prefecture, Japan |
| title_full_unstemmed | Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective Study from Aichi Prefecture, Japan |
| title_short | Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective Study from Aichi Prefecture, Japan |
| title_sort | evaluating bezlotoxumab fidaxomicin combination therapy in clostridioides infection a single center retrospective study from aichi prefecture japan |
| topic | bezlotoxumab fidaxomicin combination therapy <i>Clostridioides difficile</i> recurrence severe diarrhea |
| url | https://www.mdpi.com/2079-6382/14/3/228 |
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