Table 2.
Baseline Demographics and Clinical Characteristics in Treatment Groups (mITT Population)
| Metronidazole Stratum (N = 753), n (%) | Vancomycin Stratum (N = 745), n (%) | Fidaxomicin Stratum (N = 56), n (%) | |
|---|---|---|---|
| Age, years | |||
| Mean (SD) | 60.6 (18.4) | 64.9 (16.8) | 61.3 (18.4) |
| Median (IQR) | 62 (49–75) | 67 (56–78) | 63 (54–72) |
| ≥65 years | 343 (45.6) | 426 (57.2) | 26 (46.4) |
| ≥75 years | 194 (25.8) | 244 (32.7) | 10 (17.9) |
| Female | 433 (57.5) | 422 (56.6) | 36 (64.3) |
| Inpatient at the time of randomization | 488 (64.8) | 534 (71.7) | 28 (50.0) |
| Immunocompromiseda | 165 (21.9) | 155 (20.8) | 11 (19.6) |
| ≥1 of 5 predefined risk factors for rCDIb | 497 (66.0) | 623 (83.6) | 50 (89.3) |
| Charlson Comorbidity Index ≥3 | 304 (40.4) | 288 (38.7) | 30 (53.6) |
| Renal impairmentc | 113 (15.0) | 113 (15.2) | 7 (12.5) |
| Hepatic impairmentd | 43 (5.7) | 47 (6.3) | 3 (5.4) |
| ≥1 CDI episodes in past 6 months | 97 (12.9) | 307 (41.2) | 31 (55.4) |
| ≥1 CDI episode ever | 127 (16.9) | 342 (45.9) | 39 (69.6) |
| Number of prior CDI episodes | |||
| 0 | 613 (81.4) | 388 (52.1) | 17 (30.4) |
| 1 | 93 (12.4) | 178 (23.9) | 11 (19.6) |
| 2 | 17 (2.3) | 96 (12.9) | 16 (28.6) |
| ≥3 | 17 (2.3) | 68 (9.1) | 12 (21.4) |
| Severe CDI (Zar Scoree ≥2) | 100 (13.3) | 139 (18.7) | 8 (14.3) |
| Participants with a positive culture | 517 (68.7) | 431 (57.9) | 28 (50.0) |
| Ribotype 027, 078, or 244 | 89 (11.8) | 121 (16.2) | 7 (12.5) |
| Ribotype 027 | 72 (9.6) | 111 (14.9) | 6 (10.7) |
Abbreviations: ALT, alanine aminotransferase; CDI, Clostridioides difficile infection; IQR, interquartile range; mITT, modified intent-to-treat; rCDI, recurrent C. difficile infection; ULN, upper limit of normal; WBC, white blood cell.
aDefined as the basis of a participant’s medical history or use of immunosuppressive therapy.
bPredefined risk factors include CDI history in the past 6 months, severe CDI at baseline (per Zar score), age ≥65 years, having a hypervirulent strain (027, 078, or 244 ribotypes) at baseline, and being immunocompromised.
cSerum creatinine ≥1.5 mg/dL.
dBased on 2 or more of the following: (1) albumin ≤3.1 g/dL; (2) ALT ≥2X ULN; (3) total bilirubin ≥1.3X ULN; or (4) mild, moderate, or severe liver disease (as reported on the Charlson comorbidity index).
eBased on the following: (1) age >60 years (1 point); (2) body temperature >38.3˚C (>100˚F; 1 point); (3) albumin level <2.5 mg/dL (1 point); (4) peripheral WBC count >15 000 cells/mm3 within 48 hours (1 point); (5) endoscopic evidence of pseudomembranous colitis (2 points); and (6) treatment in intensive care unit (2 points).