TABLE 1.
Participant characteristics and CDI-related outcomes in the overall and pharmacogenetic populationsd
| Characteristic or outcome | Value for populationc
: |
|
|---|---|---|
| mITT (n = 2,559) | PGx (n = 1,001) | |
| Baseline characteristic | ||
| Age (yr) | ||
| Mean (SD) | 63.3 (17.6) | 61.9 (17.4) |
| Median | 66 | 64 |
| Range | 18–100 | 18–99 |
| Sex, female | 1,444 (56.4) | 598 (59.7) |
| ≥65 yr of age | 1,358 (53.1) | 489 (48.9) |
| ≥1 CDI episodes in past 6 months | 704 (27.5) | 286 (28.6) |
| ≥2 previous CDI episodes ever | 363 (14.2) | 170 (17.0) |
| Severe CDI (Zar score ≥2)a | 420 (16.4) | 121 (12.1) |
| Immunocompromised | 549 (21.5) | 170 (17.0) |
| Charlson comorbidity index ≥3 | 1,054 (41.2) | 360 (36.0) |
| Albumin ≤2.5 g/dl | 332 (13.0) | 104 (10.4) |
| Ribotype 027, 078, or 244 | 337 (21.1) | 119 (18.9) |
| Antibiotic use during ADT | 852 (33.3) | 296 (29.6) |
| Antibiotic use after ADT | 782 (30.6) | 275 (27.5) |
| ≥1 risk factor for rCDIb | 1,941 (75.8) | 706 (70.5) |
| Outcome | ||
| Initial clinical cure | 1,814 (70.9) | 704 (70.3) |
| rCDI | 454 (25.0) | 191 (27.1) |
Zar score based on (i) age of >60 years (1 point), (ii) body temperature of >38.3°C (1 point), (iii) albumin level of <2.5 g/dl (1 point), (iv) peripheral white blood cell count of >15,000 cells/μl within 48 h (1 point), (v) endoscopic evidence of pseudomembranous colitis (2 points), and (vi) treatment in an intensive care unit (2 points).
Prespecified risk factors for rCDI included age of ≥65 years; ≥1 CDI episodes in past 6 months; Zar score of ≥2; immunocompromised; ribotype 027, 078, or 244; and antibiotic use during/after ADT.
Data are presented as n (%) unless otherwise indicated.
Abbreviations: ADT, antibacterial drug treatment for CDI; CDI, Clostridium difficile infection; mITT, modified intent-to-treat; PGx, pharmacogenetic population; rCDI, recurrent Clostridium difficile infection.