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Evaluating Bezlotoxumab-Fidaxomicin Combination Therapy in Clostridioides Infection: A Single-Center Retrospective
Jun Hirai1,2,3, Nobuaki Mori1,2, Yuki Hanai4
1Department of Clinical Infectious Diseases, Aichi Medical University Hospital, Aichi 480-1195, Japan.
Insights
Fidaxomicin plus bezlotoxumab significantly improved cure rates for high-risk recurrent Clostridioides difficile infection (CDI) patients compared to fidaxomicin alone, offering a promising CDI management strategy.
Area of Science:
- Infectious Diseases
- Gastroenterology
- Pharmacology
Background:
- Clostridioides difficile infection (CDI) recurrence affects 30% of patients, increasing morbidity and healthcare costs.
- Fidaxomicin (FDX) and bezlotoxumab (BEZ) show promise in preventing CDI recurrence.
- Limited real-world data exist on the combination of FDX + BEZ in high-risk CDI patients.
Purpose of the Study:
- To evaluate the efficacy and safety of FDX + BEZ versus FDX alone in CDI patients with recurrence risk factors.
- To assess the impact of combination therapy on cure rates and recurrence.
- To identify factors associated with improved clinical outcomes in high-risk CDI.
Main Methods:
- Retrospective analysis of 82 high-risk CDI patients treated with FDX alone or FDX + BEZ.
- Inclusion criteria: ≥2 recurrence risk factors, FDX treatment ≥10 days.
- Outcomes: Recurrence, global/clinical cure rates, adverse events, and diarrhea resolution time.
Main Results:
- FDX + BEZ group (n=30) showed significantly higher global (86.7% vs 65.4%) and clinical cure rates (90.0% vs 69.2%) (p<0.05).
- Recurrence rates were non-significantly lower in the FDX + BEZ group (3.3% vs 11.5%).
- Multivariate analysis indicated FDX + BEZ significantly improved clinical cure (aOR 4.167).
Conclusions:
- FDX + BEZ therapy demonstrates superior efficacy and safety in high-risk CDI patients.
- Combination therapy accelerates diarrhea resolution without increasing adverse events.
- FDX + BEZ represents a promising strategy for optimizing CDI management.
Abstract:
Background/Objectives:Clostridioides difficile 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. Methods: 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. Results: Among 82 patients, the FDX + BEZ group (n = 30) demonstrated significantly higher global (86.7% vs. 65.4%; p < 0.05) and clinical cure rates (90.0% vs. 69.2%; p < 0.05) compared with the FDX-alone group (n = 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). Conclusions: FDX + BEZ therapy offers superior efficacy and safety in CDI patients with recurrence risk factors, presenting a promising strategy for optimizing CDI management.
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