Table 1.
Administered Antibacterial Drug Treatment for CDI According to Treatment Group (mITT Population)
| Bezlotoxumab (N = 781), n (%) | Placebo (N = 773), n (%) | |
|---|---|---|
| Metronidazole stratum (48.5% of participants) | 379 | 374 |
| Oral metronidazole alone | 361 (95.3) | 344 (92.0) |
| Oral metronidazole with IV metronidazole | 7 (1.8) | 2 (0.5) |
| Othera | 11 (2.9) | 28 (7.5) |
| Days on antibacterial treatment before infusionb | ||
| Mean (SD) | 3.4 (2.1) | 3.1 (2.1) |
| Median (range) | 3 (0 to 13) | 3 (0 to 11) |
| Total days on antibacterial treatmentb,c | ||
| Mean (SD) | 13.4 (3.5) | 13.7 (4.9) |
| Median (range) | 14 (2 to 37) | 13 (5 to 62) |
| Vancomycin stratum (47.6% of participants) | 372 | 373 |
| Oral vancomycin alone | 318 (85.5) | 300 (80.4) |
| Oral vancomycin with IV metronidazole | 44 (11.8) | 52 (13.9) |
| Othera | 10 (2.7) | 21 (5.6) |
| Days on antibacterial treatment before infusionb | ||
| Mean (SD) | 3.2 (2.2) | 3.3 (2.1) |
| Median (range) | 3 (0 to 14) | 3 (–1 to 13) |
| Total days on antibacterial treatmentb,c | ||
| Mean (SD) | 14.7 (7.7) | 14.3 (5.1) |
| Median (range) | 14 (4 to 87) | 14 (3 to 67) |
| Fidaxomicin stratum (3.8% of participants) | 30 | 26 |
| Oral fidaxomicin alone | 26 (86.7) | 24 (92.3) |
| Oral fidaxomicin with IV metronidazole | 1 (3.3) | 1 (3.8) |
| Othera | 3 (10.0) | 1 (3.8) |
| Days on antibacterial treatment before infusionb | ||
| Mean (SD) | 3.0 (2.9) | 3.0 (2.2) |
| Median (range) | 2 (0 to 12) | 3 (0 to 8) |
| Total days on antibacterial treatmentb,c | ||
| Mean (SD) | 11.8 (2.3) | 12.0 (2.3) |
| Median (range) | 11 (10 to 20) | 11 (10 to 21) |
Abbreviations: CDI, Clostridioides difficile infection; IV, intravenous; mITT, modified intent-to-treat.
aThe actual antibacterial drug treatment for CDI on the day of infusion differed from the stratification antibacterial drug treatment for CDI.
bData represent the number of calendar days.
cData for total days on antibacterial treatment reflect the days on therapy for all antibiotics given to treat the CDI episode under treatment at the time of randomization and include days before, the day of, and days after administration of study medication.