Table 1.
Demographics and baseline characteristics in ECOSPOR III and ECOSPOR IV
| Overall VOS exposurea (ECOSPOR III/ECOSPOR IV) N = 349 n (%) |
|
|---|---|
| Age (years) | |
| Mean (SD) | 64.2 (15.8) |
| Age group, n (%) | |
| < 65 years | 166 (47.6) |
| ≥ 65 years | 183 (52.4) |
| Sex, n (%) | |
| Female | 240 (68.8) |
| Race, n (%) | |
| American Indian or Alaska native | 1 (0.3) |
| Asian | 6 (1.7) |
| Black or African-American | 18 (5.2) |
| Native Hawaiian or other Pacific Islander | 0 |
| White | 322 (92.3) |
| Other | 2 (0.6) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 26 (7.4) |
| Non-Hispanic or Latino | 323 (92.6) |
| Number of previous CDI episodes (including the qualifying episode) | |
| 2 | 77 (22.1) |
| ≥ 3 | 271 (77.7) |
| Missing | 1 (0.3) |
| Prior antibiotic regimen (for the qualifying episode) | |
| Vancomycin | 252 (72.2) |
| Fidaxomicin | 97 (27.8) |
| Defining test for qualifying CDI episodeb | |
| PCR alone | 69 (19.8) |
| Toxin with or without PCR | 276 (79.1) |
| Age-adjusted Charlson Comorbidity Scorec | |
| Mean (SD), median [minimum; maximum] | 3.8 (2.2), 4.0 [0.0–11.0] |
| Charlson Comorbidity Score category | |
| 0 | 26 (7.5) |
| 1–2 | 71 (20.6) |
| 3–4 | 132 (38.3) |
| ≥ 5 | 116 (33.6) |
| Concomitant illnessd | |
| Renal impairment/failure | 46 (13.2) |
| Diabetes | 66 (18.9) |
| Cardiac disease | 109 (31.2) |
| Immunocompromise/immunosuppression | 74 (21.2) |
SD Standard deviation
aIncludes patients who received one (N = 345) or two (N = 4) VOS treatment regiments in ECOSPOR III and ECOSPOR IV
bTwo patients enrolled in ECOSPOR III had missing or negative assay results and are not included in the table. Two patients were enrolled in ECOSPOR IV on the basis of a positive loop-mediated isothermal amplification assay result and are not included in the table
cCharlson Comorbidity Index (age-adjusted values) [20] categorizes comorbidities based on International Classification of Diseases diagnosis codes and assigns a weighted score for each condition from 1 to 6 based on adjusted risk of mortality. A score of 0 indicates no comorbidities. A higher total score indicates higher risk of mortality. 4 patients in ECOSPOR IV had missing CCI scores
dCategories are not mutually exclusive. Patients may be included under more than 1 concomitant illness