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