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Table 3 Baseline patient demographics and clinical characteristics in the ITT population by renal function group

From: Ceftolozane/tazobactam probability of target attainment and outcomes in participants with augmented renal clearance from the randomized phase 3 ASPECT-NP trial

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)
  1. Data are shown as n (%) unless otherwise specified
  2. APACHE II Acute Physiology and Chronic Health Evaluation II, CrCl creatinine clearance, ICU intensive care unit, IQR interquartile range, ITT intention-to-treat, SOFA Sequential Organ Failure Assessment, VABP ventilator-associated bacterial pneumonia, vHABP ventilated hospital-acquired bacterial pneumonia
  3. aAntibacterial therapy received in the 14 days before the first dose of study drug
  4. bBefore randomization
  5. cSome of these patients may have been unsuccessfully treated with antibacterial therapy for the current episode of vHABP/VABP before randomization, and the denominator includes patients with vHABP; thus, this number is not an exact substitute for late VABP
  6. dPersistent or worsening signs/symptoms of vHABP/VABP after ≥ 48 h of antibacterial therapy against gram-negative pathogens