Table 2 Baseline demographics - MITT analysis set
| Â | Doripenem | Imipenem | Total |
|---|---|---|---|
| Â | ( N = 79) | ( N = 88) | ( N = 167) |
Sex, n (%) | |||
   N | 79 | 88 | 167 |
   Male | 48 (60.8) | 61 (69.3) | 109 (65.3) |
   Female | 31 (39.2) | 27 (30.7) | 58 (34.7) |
Weight (kg) | |||
   N | 79 | 88 | 167 |
   Mean (SD) | 75.5 (17.85) | 78.7 (15.66) | 77.2 (16.75) |
   Median | 75.0 | 78.0 | 76.0 |
   Range | (45; 150) | (47; 143) | (45; 150) |
Height (cm) | |||
   N | 79 | 87 | 166 |
   Mean (SD) | 170.8 (9.76) | 171.7 (8.73) | 171.3 (9.22) |
   Median | 170.0 | 170.0 | 170.0 |
   Range | (148; 193) | (150; 190) | (148; 193) |
Age (years) | |||
   N | 79 | 88 | 167 |
   Mean (SD) | 54.9 (16.10) | 53.4 (18.94) | 54.1 (17.62) |
   Median | 56.0 | 57.0 | 57.0 |
   Range | (19; 89) | (18; 88) | (18; 89) |
Race, n (%) | |||
   N | 79 | 88 | 167 |
   White | 65 (82.3) | 75 (85.2) | 140 (83.8) |
   Black or African American | 5 (6.3) | 6 (6.8) | 11 (6.6) |
   Asian | 1 (1.3) | 1 (1.1) | 2 (1.2) |
   Other | 8 (10.1) | 6 (6.8) | 14 (8.4) |
Region, n (%) | |||
   N | 79 | 88 | 167 |
   Central and South America | 20 (25.3) | 19 (21.6) | 39 (23.4) |
   Eastern Europe and Asia | 24 (30.4) | 27 (30.7) | 51 (30.5) |
   Western Europe, North America, Australia | 35 (44.3) | 42 (47.7) | 77 (46.1) |
APACHE II score group, n (%) | |||
   N | 79 | 88 | 167 |
≤15 | 34 (43.0) | 42 (47.7) | 76 (45.5) |
   16 to 19 | 24 (30.4) | 21 (23.9) | 45 (26.9) |
≥20 | 21 (26.6) | 25 (28.4) | 46 (27.5) |
CPIS, n (%) | |||
   N | 79 | 88 | 167 |
   Missing | 2 (2.5) | 1 (1.1) | 3 (1.8) |
   <6 | 4 (5.1) | 2 (2.3) | 6 (3.6) |
   6 to 7 | 43 (54.4) | 50 (56.8) | 93 (55.7) |
   8 to 9 | 23 (29.1) | 29 (33.0) | 52 (31.1) |
   >9 | 7 (8.9) | 6 (6.8) | 13 (7.8) |
SOFA score | |||
   N | 41 | 46 | 87 |
   Mean (SD) | 5.7 (2.53) | 5.2 (2.24) | 5.4 (2.38) |
   Median | 6.0 | 5.0 | 5.0 |
   Range | (0; 11) | (2; 12) | (0; 12) |
Charlson Comorbidity Index | |||
   N | 79 | 88 | 167 |
   Mean (SD) | 2.4 (2.08) | 2.8 (2.48) | 2.6 (2.30) |
   Median | 3.0 | 2.0 | 3.0 |
   Range | (0; 9) | (0; 9) | (0; 9) |
PaO 2 /FiO 2 , n (%) | Â | Â | Â |
   N | 79 | 88 | 167 |
≤250 | 50 (63.3) | 51 (58.0) | 101 (60.5) |
   >250 | 29 (36.7) | 37 (42.0) | 66 (39.5) |
Bacteremia, n (%) | Â | Â | Â |
   N | 79 | 88 | 167 |
   No | 73 (92.4) | 84 (95.5) | 157 (94.0) |
   Yes | 6 (7.6) | 4 (4.5) | 10 (6.0) |
Creatinine Clearance, n (%) | |||
   N | 79 | 88 | 167 |
   Supra normal (≥150 ml/min) | 18 (22.8) | 28 (31.8) | 46 (27.5) |
   Normal (≥80 to <150 ml/min) | 31 (39.2) | 37 (42.0) | 68 (40.7) |
   Mild renal failure (>50 to <80 ml/min) | 23 (29.1) | 18 (20.5) | 41 (24.6) |
   Moderate renal failure (>30 to ≤50 ml/min) | 5 (6.3) | 2 (2.3) | 7 (4.2) |
   Severe renal failure (≤30 ml/min) | 2 (2.5) | 3 (3.4) | 5 (3.0) |
Failed antibiotic treatment, n (%) | |||
   N | 55 | 68 | 123 |
   No | 45 (81.8) | 58 (85.3) | 103 (83.7) |
   Yes | 10 (18.2) | 10 (14.7) | 20 (16.3) |
Prior antibacterial therapy usage (hours), n (%) | |||
   N | 79 | 88 | 167 |
   <24 | 19 (24.1) | 29 (33.0) | 48 (28.7) |
≥24 to <48 | 8 (10.1) | 8 (9.1) | 16 (9.6) |
≥48 to ≤72 | 6 (7.6) | 3 (3.4) | 9 (5.4) |
   >72 | 46 (58.2) | 48 (54.5) | 94 (56.3) |
Adjunctive therapy, n (%) | |||
   N | 79 | 88 | 167 |
   No | 49 (62.0) | 68 (77.3) | 117 (70.1) |
   Yes |  |  |  |
≤72 Hrs | 23 (29.1) | 15 (17.0) | 38 (22.8) |
   >72 Hrs | 7 (8.9) | 5 (5.7) | 12 (7.2) |
Adjunctive aminoglycoside, n (%) | |||
   N | 30 | 20 | 50 |
   No | 15 (50.0) | 11 (55.0) | 26 (52.0) |
   Yes |  |  |  |
≤72 hrs | 14 (46.7) | 8 (40.0) | 22 (44.0) |
   >72 hrs | 1 (3.3) | 1 (5.0) | 2 (4.0) |
Adjunctive vancomycin/linezolid, n (%) | |||
   N | 30 | 20 | 50 |
   No | 9 (30.0) | 6 (30.0) | 15 (30.0) |
   Yes |  |  |  |
≤72 hrs | 16 (53.3) | 11 (55.0) | 27 (54.0) |
   >72 hrs | 5 (16.7) | 3 (15.0) | 8 (16.0) |