Table 1.
Demographic and disease characteristics at baseline in the bacteremia subset (microbiological modified intent-to-treat population)
| cIAI | cUTI/pyelonephritis | NP/VAP | All indications | |||||
|---|---|---|---|---|---|---|---|---|
| Ceftazidime-avibactam (n = 25) |
Comparator (n = 24) |
Ceftazidime-avibactam (n = 42) |
Comparator (n = 39) |
Ceftazidime-avibactam (n = 19) |
Meropenem (n = 15) |
Ceftazidime-avibactam (n = 86) |
Comparator (n = 78) |
|
| Age (years) | ||||||||
| Mean (SD) | 59.7 (16.7) | 55.6 (14.3) | 59.4 (19.5) | 63.6 (17.0) | 63.3 (17.4) | 62.4 (17.3) | 60.3 (18.1) | 60.9 (16.4) |
| Age group (years), n (%) | ||||||||
| ≥ 18–45 | 5 (20.0) | 6 (25.0) | 10 (23.8) | 5 (12.8) | 3 (15.8) | 2 (13.3) | 18 (20.9) | 13 (16.7) |
| 45–64 | 11 (44.0) | 9 (37.5) | 12 (28.6) | 12 (30.8) | 5 (26.3) | 4 (26.7) | 28 (32.6) | 25 (32.1) |
| 65–74 | 4 (16.0) | 6 (25.0) | 8 (19.0) | 11 (28.2) | 6 (31.6) | 6 (40.0) | 18 (20.9) | 23 (29.5) |
| ≥ 75– ≤ 90 | 5 (20.0) | 3 (12.5) | 12 (28.6) | 11 (28.2) | 5 (26.3) | 3 (20.0) | 22 (25.6) | 17 (21.8) |
| Sex, n (%) | ||||||||
| Female | 11 (44.0) | 10 (41.7) | 35 (83.3) | 31 (79.5) | 9 (47.4) | 3 (20.0) | 55 (64.0) | 44 (56.4) |
| Male | 14 (56.0) | 14 (58.3) | 7 (16.7) | 8 (20.5) | 10 (52.6) | 12 (80.0) | 31 (36.0) | 34 (43.6) |
| Race, n (%) | ||||||||
| White | 15 (60.0) | 12 (50.0) | 23 (54.8) | 25 (64.1) | 13 (68.4) | 10 (66.7) | 51 (59.3) | 47 (60.3) |
| Black or African American | 0 (0.0) | 0 (0.0) | 1 (2.4) | 2 (5.1) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 2 (2.6) |
| Asian | 8 (32.0) | 12 (50.0) | 14 (33.3) | 7 (17.9) | 6 (31.6) | 4 (26.7) | 28 (32.6) | 23 (29.5) |
| Other | 2 (8.0) | 0 (0.0) | 4 (9.5) | 5 (12.8) | 0 (0.0) | 1 (6.7) | 6 (7.0) | 6 (7.7) |
| Weight (kg) | ||||||||
| Mean (SD) | 70.8 (15.7) | 67.3 (16.4) | 67.3 (18.1) | 70.6 (15.6) | 78.9 (18.5) | 74.9 (27.6) | 71.0 (17.9) | 70.4 (18.6) |
| BMI (kg/m2) | ||||||||
| Mean (SD) | 25.7 (4.9) | 23.2 (3.7) | 25.4 (5.5) | 27.1 (5.6) | 27.7 (6.4) | 25.5 (7.1) | 26.0 (5.6) | 25.6 (5.6) |
| APACHE II scorea | ||||||||
| Mean (SD) | 9.0 (5.9) | 10.2 (6.9) | NA | NA | 16.2 (4.7) | 16.1 (4.4) | 12.1 (6.5) | 12.5 (6.6) |
| APACHE II score grouping, n (%) | ||||||||
| < 10 | 13 (52.0) | 13 (54.2) | NA | NA | 0 (0.0) | 0 (0.0) | 13 (15.1) | 13 (16.7) |
| 10–19 | 11 (44.0) | 7 (29.2) | NA | NA | 15 (78.9) | 10 (66.7) | 26 (30.2) | 17 (21.8) |
| 20–30 | 1 (4.0) | 3 (12.5) | NA | NA | 4 (21.1) | 5 (33.3) | 5 (5.8) | 8 (10.3) |
| Missing/not done | 0 (0.0) | 1 (4.2) | 42 (100) | 39 (100) | 0 (0.0) | 0 (0.0) | 42 (48.8) | 40 (51.3) |
| Renal status, n (%) | ||||||||
| ≤ 30 ml/min CrCL | 1 (4.0) | 0 (0.0) | 1 (2.4) | 1 (2.6) | 0 (0.0) | 0 (0.0) | 2 (2.3) | 1 (1.3) |
| 31–50 ml/min CrCL | 5 (20.0) | 6 (25.0) | 7 (16.7) | 10 (25.6) | 0 (0.0) | 1 (6.7) | 12 (14.0) | 17 (21.8) |
| 51–80 ml/min CrCL | 8 (32.0) | 9 (37.5) | 19 (45.2) | 22 (56.4) | 9 (47.4) | 8 (53.3) | 36 (41.9) | 39 (50.0) |
| ≥ 81 ml/min CrCL | 11 (44.0) | 9 (37.5) | 15 (35.7) | 6 (15.4) | 10 (52.6) | 6 (40.0) | 36 (41.9) | 21 (26.9) |
| Primary diagnosis, n (%) | ||||||||
| Non-VAP | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 7 (36.8) | 6 (40.0) | 7 (8.1) | 6 (7.7) |
| VAP | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 12 (63.2) | 9 (60.0) | 12 (14.0) | 9 (11.5) |
| cUTI without acute pyelonephritis | 0 (0.0) | 0 (0.0) | 4 (9.5) | 4 (10.3) | 0 (0.0) | 0 (0.0) | 4 (4.7) | 4 (5.1) |
| Acute pyelonephritis | 0 (0.0) | 0 (0.0) | 34 (81.0) | 29 (74.4) | 0 (0.0) | 0 (0.0) | 34 (39.5) | 29 (37.2) |
| Traumatic perforation | 0 (0.0) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.3) |
| Cholecystitis | 3 (12.0) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (3.5) | 1 (1.3) |
| Acute gastric and duodenal perforations | 3 (12.0) | 2 (8.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (3.5) | 2 (2.6) |
| Diverticular disease | 2 (8.0) | 3 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.3) | 3 (3.8) |
| Intra-abdominal abscess | 2 (8.0) | 3 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.3) | 3 (3.8) |
| Secondary peritonitis | 3 (12.0) | 6 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (3.5) | 6 (7.7) |
| Appendiceal perforation or peri-appendiceal abscess | 12 (48.0) | 8 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 12 (14.0) | 8 (10.3) |
APACHE Acute Physiology and Chronic Health Evaluation, BMI body mass index, cIAI complicated intra-abdominal infection, CrCL creatinine clearance, cUTI complicated urinary tract infection, NA not available, NP nosocomial pneumonia, SD standard deviation, VAP ventilator-associated pneumonia
aAPACHE II score calculated programmatically using data obtained at the site and reported in the electronic case report form for patients with cIAI and NP/VAP only. Data not collected for 42 patients with cUTI in the ceftazidime-avibactam group and 39 patients with cUTI in the comparator group