ITT population | Ceftolozane/tazobactam | Meropenem | ||
---|---|---|---|---|
Normal renal function (n = 131) | Augmented renal clearance (n = 96) | Normal renal function (n = 123) | Augmented renal clearance (n = 113) | |
Male | 93 (71.0) | 78 (81.3) | 84 (68.3) | 89 (78.8) |
Age (years) | ||||
 < 65 | 75 (57.3) | 78 (81.3) | 74 (60.2) | 96 (85.0) |
 ≥ 65 | 56 (42.7) | 18 (18.8) | 49 (39.8) | 17 (15.0) |
 Mean (SD) | 59.6 (16.5) | 49.3 (15.1) | 58.7 (15.6) | 48.2 (15.6) |
 Median (IQR) | 63.0 (49.0–71.0) | 50.0 (40.5–60.0) | 61.0 (50.0–71.0) | 49.0 (36.0–60.0) |
Weight, kg, median (IQR) | 80.0 (72.0–90.0) | 85.0 (75.0–95.5) | 79.3 (70.0–90.0) | 80.0 (72.0–95.0) |
Body mass index, kg/m2, median (IQR) | 26.8 (24.1–29.4) | 27.8 (25.1–31.1) | 26.3 (24.0–29.4) | 27.1 (24.2–30.9) |
Baseline CrCl, mL/min, median (IQR) | 99.0 (90.0–112.0) | 172.3 (145.3–204.4) | 100.5 (90.0–113.5) | 164.0 (139.6–204.0) |
Randomized while in ICU | 122 (93.1) | 89 (92.7) | 113 (91.9) | 109 (96.5) |
APACHE II score | ||||
 < 10 | 7 (5.3) | 8 (8.3) | 11 (8.9) | 14 (12.4) |
 10–14 | 25 (19.1) | 17 (17.7) | 19 (15.4) | 25 (22.1) |
 15–19 | 61 (46.6) | 45 (46.9) | 53 (43.1) | 49 (43.4) |
 20–24 | 27 (20.6) | 20 (20.8) | 27 (22.0) | 20 (17.7) |
 25–35 | 11 (8.4) | 6 (6.3) | 13 (10.6) | 4 (3.5) |
 ≥ 35 | 0 | 0 | 0 | 0 |
 Missing | 0 | 0 | 0 | 1 (0.9) |
 Mean (SD) | 17.2 (4.8) | 16.5 (4.9) | 17.4 (5.5) | 15.6 (5.1) |
 Median (IQR) | 18.0 (15.0–20.0) | 16.0 (14.0–20.0) | 17.0 (15.0–21.0) | 16.0 (12.5–19.0) |
Previous antibacterial agent usea | ||||
 Yes | 114 (87.0) | 88 (91.7) | 111 (90.2) | 100 (88.5) |
 No | 17 (13.0) | 8 (8.3) | 12 (9.8) | 13 (11.5) |
Primary diagnosis | ||||
 vHABP | 26 (19.8) | 18 (18.8) | 33 (26.8) | 15 (13.3) |
 VABP | 105 (80.2) | 78 (81.3) | 90 (73.2) | 98 (86.7) |
SOFA score | ||||
 ≤ 7 | 108 (82.4) | 77 (80.2) | 82 (66.7) | 80 (70.8) |
 > 7 | 23 (17.6) | 19 (19.8) | 41 (33.3) | 33 (29.2) |
PaO2/FiO2 ratio (mmHg) | ||||
 ≤ 240 | 100 (76.3) | 61 (63.5) | 92 (74.8) | 83 (73.5) |
 > 240 | 30 (22.9) | 33 (34.4) | 31 (25.2) | 29 (25.7) |
Clinical Pulmonary Infection Score (CPIS) | ||||
 Missing | 1 (0.8) | 2 (2.1) | 0 | 1 (0.9) |
 < 6 | 9 (6.9) | 6 (6.3) | 7 (5.7) | 14 (12.4) |
 7 | 11 (8.4) | 5 (5.2) | 11 (8.9) | 17 (15.0) |
 8 | 19 (14.5) | 13 (13.5) | 19 (15.4) | 11 (9.7) |
 > 8 | 92 (70.2) | 72 (75.0) | 86 (69.9) | 71 (62.8) |
Duration of hospitalization (days)b | ||||
 < 5 | 21 (16.0) | 23 (24.0) | 30 (24.4) | 25 (22.1) |
 ≥ 5 | 110 (84.0) | 71 (74.0) | 92 (74.8) | 88 (77.9) |
 Missing | 0 | 2 (2.1) | 1 (0.8) | 0 |
 Mean (SD) | 10.6 (7.8) | 9.0 (6.5) | 9.6 (7.2) | 8.8 (6.4) |
 Median (IQR) | 8.0 (6.0–13.0) | 8.0 (5.0–12.0) | 7.5 (5.0–12.0) | 7.0 (5.0–11.0) |
Duration of mechanical ventilation (days)b | ||||
 < 5 | 54 (41.2) | 40 (41.7) | 59 (48.0) | 51 (45.1) |
 ≥ 5c | 77 (58.8) | 55 (57.3) | 64 (52.0) | 61 (54.0) |
 Missing | 0 | 1 (1.0) | 0 | 1 (0.9) |
 Mean (SD) | 7.2 (6.3) | 21.5 (99.6) | 7.0 (6.1) | 7.5 (7.4) |
 Median (IQR) | 5.6 (3.5–9.2) | 5.9 (3.5–10.5) | 5.5 (2.8–9.0) | 5.5 (3.5–9.2) |
Previous unsuccessful antibacterial therapy for current episode of vHABP/VABPd | ||||
 Yes | 21 (16.0) | 14 (14.6) | 12 (9.8) | 14 (12.4) |
 No | 110 (84.0) | 82 (85.4) | 111 (90.2) | 99 (87.6) |
Bacteremia (gram-negative respiratory pathogen) | ||||
 Yes | 4 (3.1) | 7 (7.3) | 4 (3.3) | 10 (8.8) |
 No | 127 (96.9) | 89 (92.7) | 119 (96.7) | 103 (91.2) |