Table 1 Baseline demographics and clinical characteristics of participants with a baseline R-SOFA ≥ 2 or CV-SOFA ≥ 2 (ITT population)
Variables | Respiratory SOFA component score ≥ 2 | Cardiovascular SOFA component score ≥ 2 | ||
|---|---|---|---|---|
Ceftolozane/tazobactam (n = 312) | Meropenem (n = 321) | Ceftolozane/tazobactam (n = 84) | Meropenem (n = 99) | |
Primary diagnosis, n (%) | ||||
vHABP | 87 (27.9) | 97 (30.2) | 40 (47.6) | 34 (34.3) |
VABP | 225 (72.1) | 224 (69.8) | 44 (52.4) | 65 (65.7) |
Age, years | ||||
Median (range) | 63 (18–98) | 63 (18–92) | 66 (24–88) | 66 (18–87) |
< 65 years, n (%) | 171 (54.8) | 178 (55.5) | 37 (44.0) | 46 (46.5) |
≥ 65 years, n (%) | 141 (45.2) | 143 (44.5) | 47 (56.0) | 53 (53.5) |
Sex at birth, n (%) | ||||
Male | 224 (71.8) | 227 (70.7) | 53 (63.1) | 69 (69.7) |
Female | 88 (28.2) | 94 (29.3) | 31 (36.9) | 30 (30.3) |
Body mass index, kg/m2 | ||||
Median (range) | 27.1 (15.1–49.3) | 26.4 (15.5–67.2) | 27.5 (15.1–49.3) | 26.2 (15.6–56.0) |
n missing | 8 | 10 | 3 | 4 |
Race | ||||
Asian | 15 (4.8) | 16 (5.0) | 4 (4.8) | 3 (3.0) |
Black or African American | 9 (2.9) | 4 (1.2) | 0 | 1 (1.0) |
White | 266 (85.3) | 268 (83.5) | 74 (88.1) | 82 (82.8) |
Other | 4 (1.3) | 7 (2.2) | 2 (2.4) | 2 (2.0) |
Not reported or missing | 18 (5.8) | 26 (8.1) | 4 (4.8) | 11 (11.1) |
CLCR (mL/min) | ||||
Median (range) | 93.3 (16.0–336.2) | 99.3 (15.7–401.0)a | 74.5 (16.0–327.9) | 92.0 (16.0–352.0) |
≥ 150 (hyperclearance), n (%) | 51 (16.3) | 56 (17.4) | 14 (16.7) | 12 (12.1) |
≥ 80 (normal), n (%) | 196 (62.8) | 212 (66.0) | 41 (48.8) | 61 (61.6) |
> 50 to < 80 (mild impairment), n (%) | 73 (23.4) | 68 (21.2) | 19 (22.6) | 18 (18.2) |
≥ 30 to ≤ 50 (moderate impairment), n (%) | 29 (9.3) | 23 (7.2) | 16 (19.0) | 10 (10.1) |
≥ 15 to < 30 (severe impairment), n (%) | 14 (4.5) | 17 (5.3) | 8 (9.5) | 10 (10.1) |
< 15 (ESRD), n (%) | 0 | 0 | 0 | 0 |
APACHE II score | ||||
Median (range) | 17 (2–32) | 17 (4–39)a | 18 (8–33) | 18 (6–37) |
APACHE II score ≥ 20, n (%) | 111 (35.6) | 104 (32.5)a | 34 (40.5) | 32 (32.3) |
Total SOFA score > 7, n (%) | 93 (29.8) | 120 (37.4) | 66 (78.6) | 82 (82.8) |
CPIS > 8, n (%) | 239 (76.6) | 236 (73.5) | 56 (66.7) | 65 (65.7) |
Duration of hospitalization prior to randomization, days | ||||
Median (range) | 8 (1–58) | 7 (1–109) | 8 (1–42) | 6 (1–116) |
n missing | 2 | 2 | 1 | 1 |
Duration of MV prior to randomization, days | ||||
Median (range) | 4.8 (0–35.6) | 4.7 (0–107.5) | 3.1 (0–24.3) | 3.9 (0–79.0) |
n missing | 0 | 2 | 0 | 0 |
Randomized while in the ICU, n (%) | 294 (94.2) | 297 (92.5) | 70 (83.3) | 93 (93.9) |
Failed prior antibacterial(s) for vHABP/VABP, n (%) | 45 (14.4) | 31 (9.7) | 15 (17.9) | 6 (6.1) |
Prior antibacterial therapy, n (%) | 275 (88.1) | 285 (88.8) | 78 (92.9) | 91 (91.9) |
Bacteremia (any pathogen), n (%) | 51 (16.3) | 40 (12.5) | 12 (14.3) | 11 (11.1) |
Gram-negative adjunctive therapy, n (%) | 90 (28.8) | 96 (29.9)b | 33 (39.3) | 36 (36.4) |
Gram-positive adjunctive therapy, n (%) | 303 (97.1) | 309 (96.3)a | 80 (95.2) | 96 (97.0) |