Table 1.
Trial Population Demographic and Baseline Characteristicsa
| Characteristic | Treatment Arm | Total (N = 570) | |
|---|---|---|---|
| Surotomycin (N = 290) | Vancomycin (N = 280) | ||
| Female, n (%) | 117 (40.3) | 114 (40.7) | 231 (40.5) |
| Race, n (%) | |||
| Black or African American | 15 (5.2) | 22 (7.9) | 37 (6.5) |
| White | 260 (89.7) | 248 (88.6) | 508 (89.1) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 18 (6.2) | 9 (3.2) | 27 (4.7) |
| Not Hispanic or Latino | 266 (91.7) | 264 (94.3) | 530 (93.0) |
| Age at first dose (years) | |||
| Mean (SD) | 61.1 (17.6) | 61.5 (18.4) | 61.3 (18.0) |
| Median (range) | 64.0 (18‒89) | 64.5 (18‒89) | 64.0 (18‒89) |
| <75 years, n (%) | 211 (72.8) | 200 (71.4) | 411 (72.1) |
| Body mass index (kg/m2) | |||
| Mean (SD) | 26.4 (7.2) | 27.5 (6.7) | 26.9 (7.0) |
| Subject’s hospitalization status at baseline, n (%) | |||
| Inpatient | 178 (61.4) | 181 (64.6) | 359 (63.0) |
| Outpatient | 108 (37.2) | 90 (32.1) | 198 (34.7) |
| ICU status at baseline, n (%) | |||
| Yes | 11 (3.8) | 8 (2.9) | 19 (3.3) |
| CDI Epidemiologic Classification, n (%) | |||
| 1 ‒ HCF-onset, HCF-associated CDI | 92 (31.7) | 91 (32.5) | 183 (32.1) |
| 2 ‒ Community-onset, HCF-associated CDI | 53 (18.3) | 53 (18.9) | 106 (18.6) |
| 3 ‒ Community-associated CDI | 121 (41.7) | 103 (36.8) | 224 (39.3) |
| 4 ‒ Indeterminate disease | 24 (8.3) | 33 (11.8) | 57 (10.0) |
| Severe disease, n (%) | |||
| ESCMID Comprehensive Criteria | 215 (74.1) | 209 (74.6) | 424 (74.4) |
| ESCMID Abbreviated Criteria | 1 (0.3) | 0 | 1 (0.2) |
| IDSA Criteria | 9 (3.1) | 15 (5.4) | 24 (4.2) |
| UBM and WBC Criteria | 95 (32.9) | 96 (34.3) | 191 (33.6) |
| Horn’s Index | 47 (16.4) | 45 (16.3) | 92 (16.4) |
| ≥1 previous episode of CDI | 49 (17.1) | 51 (18.5) | 100 (17.8) |
| BI/NAP1/027 strain-positive | 59 (23.1) | 67 (27.2) | 126 (25.1) |
| Mean number of UBMs at baseline (SD) | 7.1 (4.6) | 6.6 (4.3) | 6.9 (4.5) |
Abbreviations: CDI, Clostridium difficile infection; ESCMID, European Society of Clinical Microbiology and Infectious Diseases; HCF, healthcare facility; ICU, intensive care unit; IDSA, Infectious Diseases Society of America; SD, standard deviation; UBM, unformed bowel movements; WBC, white blood cells.
a
Baseline values were taken as the last nonmissing result before first administration of the study drug. Therefore, some numbers do not represent the total number of initially enrolled subjects.