Table 2.
Baseline characteristics in ASPECT-NP participants who were failing prior antibacterial therapy
| C/T (N = 53) | MEM (N = 40) | Total (N = 93) | |
|---|---|---|---|
| Primary diagnosis, n (%) | |||
| VABP | 33 (62.3) | 23 (57.5) | 56 (60.2) |
| vHABP | 20 (37.7) | 17 (42.5) | 37 (39.8) |
| Sex, n (%) | |||
| Male | 43 (81.1) | 24 (60.0) | 67 (72.0) |
| Female | 10 (18.9) | 16 (40.0) | 26 (28.0) |
| Age, years | |||
| < 65, n (%) | 26 (49.1) | 20 (50.0) | 46 (49.5) |
| ≥ 65, n (%) | 27 (50.9) | 20 (50.0) | 47 (50.5) |
| Mean (SD) | 60.2 (18.7) | 61.3 (15.6) | 60.7 (17.4) |
| Median (range) | 65.0 (21, 88) | 63.5 (29, 92) | 65.0 (21, 92) |
| Weight (kg) | |||
| Median (range) | 80.0 (34.0, 119.5) | 70.5 (45.0, 225.0) | 76.0 (34.0, 225.0) |
| Body-mass index (kg/m2) | |||
| Median (range) | 26.8 (15.1, 43.3) | 25.8 (16.2, 67.2) | 26.0 (15.1, 67.2) |
| Creatinine clearance, mL/min, n (%) | |||
| ≥ 150 (augmented renal clearance) | 9 (17.0) | 6 (15.0) | 15 (16.1) |
| ≥ 80 | 35 (66.0) | 26 (65.0) | 61 (65.6) |
| < 80 to > 50 | 11 (20.8) | 9 (22.5) | 20 (21.5) |
| ≤ 50 to ≥ 30 | 5 (9.4) | 3 (7.5) | 8 (8.6) |
| < 30 to ≥ 15 | 2 (3.8) | 2 (5.0) | 4 (4.3) |
| < 15 (end-stage renal disease) | 0 | 0 | 0 |
| APACHE II score | |||
| ≤ 14, n (%) | 13 (24.5) | 13 (32.5) | 26 (28.0) |
| 15–19, n (%) | 17 (32.1) | 17 (42.5) | 34 (36.6) |
| ≥ 20, n (%) | 23 (43.4) | 10 (25.0) | 33 (35.5) |
| Mean (SD) | 18.1 (5.2) | 17.0 (5.2) | 17.6 (5.2) |
| Median (range) | 18.0 (7, 32) | 16.0 (4, 29) | 17.0 (4, 32) |
| SOFA score, n (%) | |||
| ≤ 7 | 36 (67.9) | 34 (85.0) | 70 (75.3) |
| > 7 | 17 (32.1) | 6 (15.0) | 23 (24.7) |
| Adjunctive gram-negative therapy,a n (%) | |||
| Yes | 13 (24.5) | 12 (30.0) | 25 (26.9) |
| No | 40 (75.5) | 28 (70.0) | 68 (73.1) |
| CPIS, n (%) | |||
| ≤ 6 | 6 (11.3) | 2 (5.0) | 8 (8.6) |
| 7 | 4 (7.5) | 8 (20.0) | 12 (12.9) |
| 8 | 10 (18.9) | 5 (12.5) | 15 (16.1) |
| > 8 | 33 (62.3) | 25 (62.5) | 58 (62.4) |
| Duration of prior hospitalizationb (days) | |||
| < 5, n (%) | 8 (15.1) | 5 (12.5) | 13 (14.0) |
| ≥ 5, n (%) | 43 (81.1) | 35 (87.5) | 78 (83.9) |
| Missing, n (%) | 2 (3.8) | 0 | 2 (2.2) |
| Mean (SD) | 12.0 (8.4) | 11.0 (7.3) | 11.5 (7.9) |
| Median (range) | 10.0 (2, 44) | 9.0 (1, 41) | 9.0 (1, 44) |
| Duration of prior mechanical ventilationb (days) | |||
| < 5, n (%) | 21 (39.6) | 16 (40.0) | 37 (39.8) |
| ≥ 5, n (%) | 31 (58.5) | 23 (57.5) | 54 (58.1) |
| Missing, n (%) | 1 (1.9) | 1 (2.5) | 2 (2.2) |
| Mean (SD) | 7.3 (5.6) | 8.4 (6.8) | 7.7 (6.1) |
| Median (range) | 6.4 (0.2, 26.0) | 7.3 (0.8, 25.7) | 6.6 (0.2, 26.0) |
| PaO2/FiO2, mm Hg, n (%) | |||
| ≤ 240 | 41 (77.4) | 23 (57.5) | 64 (68.8) |
| > 240 | 12 (22.6) | 16 (40.0) | 28 (30.1) |
| Missing | 0 | 1 (2.5) | 1 (1.1) |
| Bacteremia (any pathogen), n (%) | |||
| Yes | 2 (3.8) | 5 (12.5) | 7 (7.5) |
| No | 51 (96.2) | 35 (87.5) | 86 (92.5) |
| Number of baseline LRT pathogens, n (%) | |||
| None confirmed | 4 (7.5) | 8 (20.0) | 12 (12.9) |
| Monomicrobial | 32 (60.4) | 21 (52.5) | 53 (57.0) |
| Polymicrobial | 17 (32.1) | 11 (27.5) | 28 (30.1) |
| Vasopressor use, n (%) | |||
| Yes | 23 (43.4) | 15 (37.5) | 38 (40.9) |
| No | 30 (56.6) | 25 (62.5) | 55 (59.1) |
Participants included represent the ITT population
APACHE Acute Physiology and Chronic Health Evaluation, CPIS Clinical Pulmonary Infection Score, C/T Ceftolozane/tazobactam, ICU Intensive care unit, LRT Lower respiratory tract, ITT Intention-to-treat, MEM Meropenem, NP Nosocomial pneumonia, PaO2/FiO2 Arterial oxygen partial pressure to fractional inspired oxygen, SOFA Sequential Organ Failure Assessment, vHABP Ventilated hospital-acquired bacterial pneumonia, VABP Ventilator-associated bacterial pneumonia
aDefined as adjunctive empirical therapy with amikacin, which was protocol permitted for up to 72 h at study sites where ≥ 15% of P. aeruginosa isolates were resistant to meropenem according to the site’s most recent antibiogram
bAssessed prior to randomization