Table 1.
Baseline patient demographics and clinical characteristics.
| Characteristic | Fidaxomicin-treated (main analysis) population, N = 294 | Non-fidaxomicin treated (registry) population,a N = 150 |
|---|---|---|
| Female, n (%) | 179 (60.9) | 80 (53.3) |
| Age in years, mean (SD) | 68.4 (17.3) | 67.8 (17.2) |
| Time between healthcare facility admission and CDI diagnosis, days (SD) | 15.4 (34.3) | 11.9 (17.8) |
| Immunocompromised, n (%) | 115 (39.1) | 39 (26.0) |
| Charlson Comorbidity Index (SD) | 5.9 (3.4) | N/A |
| Severe CDI according to 2014 ESCMID criteria, n (%)b | 174 (59.2) | 53 (35.8) |
| Prior treatment during previous 3 months, n (%) | ||
| Antibiotic therapyc | 248 (84.6) | N/A |
| PPI used | 166 (56.7) | N/A |
| Concomitant antibiotic therapy at the time of diagnosis, n (%)e | 132 (45.1) | 67 (45.0) |
| Presence of clinical symptoms consistent with C. difficile diarrhoea, n (%) | 291 (99.0) | 144 (96.0) |
| UBMs per day, mean (SD)f | 5.5 (3.2) | 5.1 (2.8) |
| CDI status, n (%) | ||
| Initial | 186 (63.3) | 132 (88.0) |
| Recurrence | 107 (36.4) | 14 (9.3) |
| Unknown | 1 (0.3) | 4 (2.7) |
| Number of recurrences, n (%)g | ||
| 1 | 65 (61.3) | 3 (23.1) |
| 2 | 18 (17.0) | 7 (53.8) |
| ≥3 | 23 (21.7) | 3 (23.1) |
| CDI origin, n (%) | ||
| Healthcare-associated | 219 (74.5) | 92 (61.3) |
| Community-associated | 55 (18.7) | 51 (34.0) |
| Unknown | 20 (6.8) | 7 (4.7) |
| Treatment of CDI, n (%)h,i | ||
| Metronidazole, oral | N/A | 80 (55.6) |
| Metronidazole, IV | N/A | 13 (9.0) |
| Vancomycin, oral | N/A | 60 (41.7) |
| Other | N/A | 6 (4.1) |
| No treatment | N/A | 5 (3.3) |
| Time between sample collection and confirmed CDI diagnosis, days, mean (SD) | 1.3 (1.6) | 1.0 (2.1) |
| PCR ribotyping done, n (%)j | 56 (19.2) | 13 (8.7) |
aThe questionnaire in relation to patients in the registry population did not include the same level of detail as that for the main analysis population, which accounts for the missing information.
Patient numbers in the main analysis and registry populations, respectively, were: b294 and 148; c293 and N/A; d293 and N/A; e293 and 149; f188 and 119; g106 and 13; hN/A and 144 (except 145 for Other); i292 and 150.
jFor the main analysis population, prior and concomitant treatments other than fidaxomicin are provided in Table 2.
C. difficile, Clostridioides difficile; CDI, Clostridioides difficile infection; ESCMID, European Society of Clinical Microbiology and Infectious Diseases; IV, intravenous; n, number of patients with the characteristic; N, number of patients with information available; N/A, not applicable; PCR, polymerase chain reaction; PPI, proton pump inhibitor; SD, standard deviation, UBM, unformed bowel movement.