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Table 2 Patient demographics and disease characteristics at baseline (MITT/cIAI population and mMITT/cUTI population)

From: Analysis of patients with diabetes and complicated intra-abdominal infection or complicated urinary tract infection in phase 3 trials of ceftolozane/tazobactam

Parameter Diabetes n = 198 No diabetes n = 1408 Differencea; P value
cIAI, n (%) 65 (32.8) 741 (52.6)
cUTI, n (%) 133 (67.2) 667 (47.4)
Sex, n (%)
 Male 73 (36.9) 601 (42.7) 5.8; 0.12061
 Female 125 (63.1) 807 (57.3) −5.8; 0.12061
Age, years
 Mean (SD) 60 (13.9) 48 (18.9)
  ≥ 18–<65, n (%) 123 (62.1) 1099 (78.1) 15.9; <0.00001
  ≥ 65–<75, n (%) 46 (23.2) 166 (11.8) −11.4; <0.00001
  > 75, n (%) 29 (14.6) 143 (10.2) −4.5; 0.05581
Race, n (%)
 White 159 (80.3) 1282 (91.1) 10.7; <0.00001
 Black 0 (0.0) 17 (1.2) 1.2; 0.12020
 Asian 30 (15.2) 64 (4.5) −10.6; <0.00001
 Other 9 (4.5) 45 (3.2) −1.4; 0.29496
Geographic region, n (%)
 North America 17 (8.6) 59 (4.2) −4.4; 0.00640
 South America 26 (13.1) 127 (9.0) −4.1; 0.06511
 Western Europe 3 (1.5) 27 (1.9) 0.4; 0.69541
 Eastern Europe 118 (59.6) 1095 (77.8) 18.2; <0.00001
 Rest of world 34 (17.2) 100 (7.1) −10.1; <0.00001
Weight, kg
 Mean (SD) 79 (17.2) 74 (17.2) −5.28; 0.00003
  ≥ 75 kg, n (%) 113 (57.1) 627 (44.5) −12.5; 0.00092
BMI, kg/m2, mean (SD) 29 (5.8) 26 (5.4) −3.24; <0.00001
APACHE II score (cIAI), N b 65 740  
  < 10, n (%) 43 (66.2) 614 (83.0) −16.8; <0.0008
  ≥ 10, n (%) 22 (33.8) 126 (17.0)  
Baseline creatinine clearance, n (%)
 Missing 1 (0.5) 0 (0.0)  
 Normal, ≥80 mL/min 101 (51.0) 983 (69.8) 18.8; <0.00001
 Impairment, <80 mL/min 96 (48.5) 425 (30.2)
  Mild, ≥50 to <80 mL/min 64 (32.2) 359 (25.5) −6.8; 0.04123
  Moderate, ≥30 to <50 mL/min 31 (15.7) 63 (4.5) −11.2; <0.00001
  Severe, <30 mL/min 1 (0.5) 3 (0.2) −0.3; 0.44038
Disease type, n (%)c
 cIAI, N 65 741
  Acute gastric or duodenal perforation 4 (6.2) 67 (9.0) 2.9; 0.43116
  Appendiceal perforation or periappendiceal abscess 14 (21.5) 364 (49.1) 27.6; 0.00002
  Cholecystitis, including gangrenous 21 (32.3) 120 (16.2) −16.1; 0.00105
  Diverticular disease with perforation or abscess 8 (12.3) 57 (7.7) −4.6; 0.19036
  Traumatic perforation of the intestine 0 (0.0) 12 (1.6) 1.6; 0.30158
  Peritonitis 8 (12.3) 66 (8.9) −3.4; 0.36290
  Other intra-abdominal abscess 10 (15.4) 55 (7.4) −8.0; 0.02388
 cUTI, N 133 667
  Pyelonephritis 106 (79.7) 550 (82.5) 2.8; 0.44971
  cLUTI 27 (20.3) 117 (17.5) −2.8; 0.44971
  Treatment group, n (%)c
 cIAI, N 65 741
  Ceftolozane/tazobactam + metronidazole 32 (49.2) 357 (48.2) −1.1; 0.87072
  Meropenem 33 (50.8) 384 (51.8) 1.1; 0.87072
 cUTI, N 133 667
  Ceftolozane/tazobactam 67 (50.4) 331 (49.6) −0.8; 0.87444
  Levofloxacin 66 (49.6) 336 (50.4) 0.8; 0.87444
  1. APACHE II Acute Physiology and Chronic Health Evaluation II, BMI body mass index, cIAI complicated intra-abdominal infection, cLUTI complicated lower urinary tract infection, cUTI complicated urinary tract infection, MITT microbiologic intention-to-treat, mMITT modified microbiologic intention-to-treat, SD standard deviation
  2. aPercentage difference calculated for patients with history of diabetes versus those with no history of diabetes
  3. bExpressed as a percentage of the patients with or without diabetes in the cIAI population only
  4. cExpressed as a percentage of the patients with or without diabetes in the cIAI or cUTI population