Table 4.
Risk Factors for CDI Recurrence (Modified Intent-to-Treat Population)
| Risk Factor | Bezlotoxumab (N = 104) | Placebo (N = 35) | Total (N = 139) | |||
|---|---|---|---|---|---|---|
| Immunocompromised | 73 | (70.2) | 28 | (80.0) | 101 | (72.7) |
| ≥1 CDI prior to baseline episode | 33 | (31.7) | 10 | (28.6) | 43 | (30.9) |
| Severe baseline CDI episode | 20 | (19.2) | 5 | (14.3) | 25 | (18.0) |
| C. difficile ribotype 027 | 3 | (2.9) | 1 | (2.9) | 4 | (2.9) |
| Systemic antibacterial treatmenta | 67 | (64.4) | 20 | (57.1) | 87 | (62.6) |
| Number of risk factors for CDI recurrence | ||||||
| 1 | 20 | (19.2) | 9 | (25.7) | 29 | (20.9) |
| 2 | 60 | (57.7) | 20 | (57.1) | 80 | (57.6) |
| 3 | 14 | (13.5) | 5 | (14.3) | 19 | (13.7) |
| 4 | 1 | (1.0) | 0 | (0.0) | 1 | (0.7) |
| 5 | 2 | (1.9) | 0 | (0.0) | 2 | (1.4) |
| No criteria met | 7 | (6.7) | 1 | (2.9) | 8 | (5.8) |
Abbreviation: CDI, Clostridioides difficile infection.
aTreatment with ≥1 systemic antibacterials on or before randomization, along with standard-of-care treatment for CDI baseline episode