Table 1.
Demographics and baseline characteristics of participants, mFAS
| Characteristic | EPFX (n = 177) | Vancomycin (n = 179) | Total (n = 356) |
|---|---|---|---|
| Gender, n (%) | |||
| Female | 107 (60.5) | 100 (55.9) | 207 (58.1) |
| Race, n (%)a | |||
| White | 149 (84.2) | 153 (85.5) | 302 (84.8) |
| Missing | 28 (15.8) | 26 (14.5) | 54 (15.2) |
| Median (range) age, years | 75.0 (60–94) | 75.0 (60–95) | 75.0 (60–95) |
| UBMs per day, nb | |||
| Mean (SD) | 6.8 (4.7) | 6.4 (3.4) | 6.6 (4.1) |
| Median | 5.0 | 5.0 | 5.0 |
| Severe CDI at baseline, n (%)c | 63 (35.6) | 67(37.4) | 130 (36.5) |
| Severe CDI by ESCMID score, n (%) | 78 (44.1) | 84 (46.9) | 162 (45.5) |
| No. previous CDI occurrences in the past 3 months, n (%) | |||
| 0 | 141 (79.7) | 140 (78.2) | 281 (78.9) |
| 1 | 26 (14.7) | 29 (16.2) | 55 (15.4) |
| 2 | 10 (5.6) | 10 (5.6) | 20 (5.6) |
| Cancer present, n (%)c | 38 (21.5) | 37 (20.7) | 75 (21.1) |
| Use of antibiotics for condition other than CDI, n (%) | |||
| Yes | 128 (72.3) | 129 (72.1) | 257 (72.2) |
| Residential setting, n (%) | n = 175 | n = 179 | n = 354 |
| Own residence | 102 (58.3) | 103 (57.5) | 205 (57.9) |
| Family residence | 66 (37.7) | 59 (33.0) | 125 (35.3) |
| Nursing home | 4 (2.3) | 6 (3.4) | 10 (2.8) |
| Long-term care facility | 1 (0.6) | 4 (2.2) | 5 (1.4) |
| Other | 2 (1.1) | 7 (3.9) | 9 (2.5) |
| Missing | 2 | 0 | 2 |
| C. difficile PCR-ribotype | |||
| 027 | 25 (14.1) | 22 (12.3) | 47 (13.2) |
| Other | 152 (85.9) | 157 (87.7) | 309 (86.8) |
EPFX, extended-pulsed fidaxomicin; mFAS, modified full analysis set (all patients with confirmed CDI who were randomised and received at least one dose of study medication); SD, standard deviation; UBMs, unformed bowel movements
aNot all study sites were permitted to report the race of participants; this information was reported as ‘missing’. bIn the last 24 h prior to randomisation. cAs provided in the Interactive Web Response System at randomisation, and defined as leukocyte count > 15 × 109/L or rise in serum creatinine > 50% above the patient’s normal level or albumin < 30 g/L