Table 1.
Baseline (at Randomization) Demographics and Clinical Characteristics in the Modified Intent-to-Treat Population
| Characteristic | IMI/REL (n = 264) | PIP/TAZ (n = 267) | Total (N = 531) |
|---|---|---|---|
| Sex | |||
| Female | 86 (32.6) | 78 (29.2) | 164 (30.9) |
| Male | 178 (67.4) | 189 (70.8) | 367 (69.1) |
| Age, y | |||
| <65 | 151 (57.2) | 152 (56.9) | 303 (57.1) |
| ≥65 | 113 (42.8) | 115 (43.1) | 228 (42.9) |
| Mean (SD) | 60.5 (16.9) | 58.8 (18.4) | 59.6 (17.7) |
| Median (range) | 62.0 (18–96) | 62.0 (18–98) | 62.0 (18–98) |
| Geographic region | |||
| Americas | 59 (22.3) | 71 (26.6) | 130 (24.5) |
| United States | 5 (1.9) | 15 (5.6) | 20 (3.8) |
| Europe | 166 (62.9) | 160 (59.9) | 326 (61.4) |
| Asia and Australia | 39 (14.8) | 36 (13.5) | 75 (14.1) |
| Weight, kg, median (range) | 75.0 (26.8–150.5) | 78.0 (27.7–145.0) | 76.2 (26.8–150.5) |
| BMI, kg/m2, median (range) | 25.9 (12.6–52.1) | 25.6 (13.7–62.8) | 25.7 (12.6–62.8) |
| Creatinine clearance, mL/mina | |||
| ≥150 (augmented renal clearance) | 38 (14.4) | 50 (18.7) | 88 (16.6) |
| ≥90 to <150 (normal renal function) | 103 (39.0) | 85 (31.8) | 188 (35.4) |
| <90 to ≥60 (mild renal impairment) | 52 (19.7) | 72 (27.0) | 124 (23.4) |
| <60 to ≥30 (moderate renal impairment) | 61 (23.1) | 48 (18.0) | 109 (20.5) |
| <30 to ≥15 (severe renal impairment) | 10 (3.8) | 12 (4.5) | 22 (4.1) |
| Elevated hepatic enzymesb | |||
| Yes | 71 (26.9) | 91 (34.1) | 162 (30.5) |
| No | 178 (67.4) | 161 (60.3) | 339 (63.8) |
| Missing | 15 (5.7) | 15 (5.6) | 30 (5.6) |
| In the ICU | |||
| Yes | 175 (66.3) | 176 (65.9) | 351 (66.1) |
| No | 89 (33.7) | 91 (34.1) | 180 (33.9) |
| APACHE II score | |||
| <15 | 139 (52.7) | 140 (52.4) | 279 (52.5) |
| ≥15 | 125 (47.3) | 127 (47.6) | 252 (47.5) |
| Mean (SD) | 14.6 (6.2) | 14.8 (6.7) | 14.7 (6.4) |
| Median (range) | 14.0 (2–31) | 14.0 (1–37) | 14.0 (1–37) |
| Primary diagnosis | |||
| Nonventilated HABP | 142 (53.8) | 131 (49.1) | 273 (51.4) |
| Ventilated HABP/VABP | 122 (46.2) | 136 (50.9) | 258 (48.6) |
| Ventilated HABP | 31 (11.7) | 35 (13.1) | 66 (12.4) |
| VABP | 91 (34.5) | 101 (37.8) | 192 (36.2) |
| CPIS | |||
| <6 | 114 (43.2) | 95 (35.6) | 209 (39.4) |
| ≥6 | 150 (56.8) | 172 (64.4) | 322 (60.6) |
| Mean (SD) | 5.9 (1.8) | 6.1 (1.8) | 6.0 (1.8) |
| Median (range) | 6.0 (1–10) | 6.0 (1–10) | 6.0 (1–10) |
| Duration of prior hospitalization, d | |||
| Mean (SD) | 30.4 (126.1) | 31.1 (143.0) | 30.7 (134.7) |
| Median (range) | 8.0 (1–1169) | 7.0 (1–1338) | 8.0 (1–1338) |
| Missing | 0 | 1 (0.4) | 1 (0.2) |
| Received systemic antibacterial with gram-negative activity within 72 h prior to first dose | |||
| No | 155 (58.7) | 136 (50.9) | 291 (54.8) |
| Yes (≤24 h) | 54 (20.5) | 68 (25.5) | 122 (23.0) |
| Yes (>24 to ≤72 h) | 55 (20.8) | 63 (23.6) | 118 (22.2) |
| Concurrent bacteremia | |||
| Yes (with any pathogen) | 15 (5.7) | 16 (6.0) | 31 (5.8) |
| Yes (with baseline LRT pathogen) | 5 (1.9) | 7 (2.6) | 12 (2.3) |
| No | 249 (94.3) | 251 (94.0) | 500 (94.2) |
| No. of baseline LRT pathogens | |||
| Monomicrobial | 160 (60.6) | 160 (59.9) | 320 (60.3) |
| Polymicrobial | 55 (20.8) | 58 (21.7) | 113 (21.3) |
| None | 49 (18.6) | 49 (18.4) | 98 (18.5) |
| Baseline LRT pathogen (≥10% in either treatment arm)c | (n = 215) | (n = 218) | (N = 433) |
| Klebsiella pneumoniae | 58 (27.0) | 53 (24.3) | 111 (25.6) |
| Pseudomonas aeruginosa | 34 (15.8) | 48 (22.0) | 82 (18.9) |
| Acinetobacter calcoaceticus-baumannii complex | 32 (14.9) | 36 (16.5) | 68 (15.7) |
| Escherichia coli | 30 (14.0) | 37 (17.0) | 67 (15.5) |
| MSSA | 23 (10.7) | 22 (10.1) | 45 (10.4) |
Data are presented as no. (%) unless otherwise indicated.
Abbreviations: APACHE II, Acute Physiology and Chronic Health Evaluation II; CPIS, Clinical Pulmonary Infection Score; HABP, hospital-acquired bacterial pneumonia; ICU, intensive care unit; IMI/REL, imipenem/cilastatin with relebactam; LRT, lower respiratory tract; MSSA, methicilin-susceptible Staphylococcus aureus; PIP/TAZ, piperacillin/tazobactam; SD, standard deviation; VABP, ventilator-associated bacterial pneumonia.
aCreatinine clearance was estimated using the Cockcroft-Gault equation.
bDefined as either alanine aminotransferase or aspartate aminotransferase being greater than the upper limit of normal at randomization.
cBaseline pathogens were assessed in the microbiologic modified intent-to-treat population.