Table 2.
Baseline Demographics and Clinical Characteristics (Safety Population)
| IMI/REL (n = 31) | Colistin + IMI (n = 16) | Total (n = 47) | |
|---|---|---|---|
| Sex, No. (%) | |||
| Male | 20 (64.5) | 10 (62.5) | 30 (63.8) |
| Female | 11 (35.5) | 6 (37.5) | 17 (36.2) |
| Age | |||
| <65 y, No. (%) | 19 (61.3) | 7 (43.8) | 26 (55.3) |
| ≥65 y, No. (%) | 12 (38.7) | 9 (56.3) | 21 (44.7) |
| Median (range) | 59 (19–77) | 66 (22–80) | 59 (19–80) |
| Weight, kg | |||
| Median (range) | 76 (49.0–140.0) | 73.5 (52.8–117.0) | 75.8 (49–140.0) |
| APACHE II score, No. (%) | |||
| ≤15 | 22 (71.0) | 12 (75.0) | 34 (72.3) |
| >15 | 9 (29.0) | 4 (25.0) | 13 (27.7) |
| Primary diagnosis, No. (%) | |||
| HABP | 1 (3.2) | 1 (6.3) | 2 (4.3) |
| VABP | 9 (29.0) | 5 (31.3) | 14 (29.8) |
| cIAI | 5 (16.1) | 3 (18.8) | 8 (17.0) |
| cUTI (urinary tract abnormalities) | 9 (29.0) | 3 (18.8) | 12 (25.5) |
| cUTI (acute pyelonephritis) | 7 (22.6) | 4 (25.0) | 11 (23.4) |
| CrCl, No. (%) | |||
| ≥90 mL/min | 10 (32.3) | 6 (37.5) | 16 (34.0) |
| <90 to ≥60 mL/min | 14 (45.2) | 5 (31.3) | 19 (40.4) |
| <60 to ≥30 mL/min | 5 (16.1) | 3 (18.8) | 8 (17.0) |
| <30 to ≥15 mL/min | 1 (3.2) | 2 (12.5) | 3 (6.4) |
| Not available | 1 (3.2) | 0 (0.0) | 1 (2.1) |
Abbreviations: APACHE II, Acute Physiologic Assessment and Chronic Health Evaluation II; cIAI, complicated intra-abdominal infection; CrCl, creatinine clearance; cUTI, complicated urinary tract infection; HABP, hospital-acquired bacterial pneumonia; IMI, imipenem/cilastatin; IMI/REL, imipenem/cilastatin plus relebactam; VABP, ventilator-associated bacterial pneumonia.