Table 1 Baseline demographics - ITT analysis set
| Â | Doripenem | Imipenem | Total |
|---|---|---|---|
| Â | ( N = 115) | ( N = 112) | ( N = 227) |
Sex, n (%) | |||
   N | 115 | 112 | 227 |
   Male | 72 (62.6) | 75 (67.0) | 147 (64.8) |
   Female | 43 (37.4) | 37 (33.0) | 80 (35.2) |
Weight (kg) | |||
   N | 115 | 112 | 227 |
   Mean (SD) | 75.6 (16.95) | 79.8 (19.07) | 77.7 (18.11) |
   Median | 74.0 | 77.5 | 75.0 |
   Range | (45;150) | (47; 170) | (45; 170) |
Height (cm) | |||
   N | 114 | 110 | 224 |
   Mean (SD) | 169.5 (10.66) | 171.3 (9.20) | 170.3 (9.99) |
   Median | 170.0 | 170.0 | 170.0 |
   Range | (140; 193) | (150; 200) | (140; 200) |
Age (Years) | |||
N | 115 | 112 | 227 |
Mean (SD) | 57.5 (16.53) | 54.6 (18.46) | 56.1 (17.53) |
Median | 58.0 | 58.0 | 58.0 |
Range | (19; 89) | (18; 88) | (18; 89) |
Race, n (%) | |||
   N | 115 | 112 | 227 |
   White | 96 (83.5) | 97 (86.6) | 193 (85.0) |
   Black or African American | 6 (5.2) | 6 (5.4) | 12 (5.3) |
   Asian | 4 (3.5) | 1 (0.9) | 5 (2.2) |
   Other | 9 (7.8) | 8 (7.1) | 17 (7.5) |
Region, n (%) | |||
   N | 115 | 112 | 227 |
   Central and South America | 24 (20.9) | 24 (21.4) | 48 (21.1) |
   Eastern Europe and Asia | 34 (29.6) | 33 (29.5) | 67 (29.5) |
   Western Europe, North America, Australia | 57 (49.6) | 55 (49.1) | 112 (49.3) |
APACHE II score, n (%) | |||
   N | 115 | 112 | 227 |
≤15 | 48 (41.7) | 49 (43.8) | 97 (42.7) |
   16 to 19 | 30 (26.1) | 34 (30.4) | 64 (28.2) |
≥20 | 37 (32.2) | 29 (25.9) | 66 (29.1) |
CPIS, n (%) | |||
   N | 115 | 112 | 227 |
   Missing | 3 (2.6) | 2 (1.8) | 5 (2.2) |
   <6 | 8 (7.0) | 5 (4.5) | 13 (5.7) |
   6 to 7 | 64 (55.7) | 64 (57.1) | 128 (56.4) |
   8 to 9 | 30 (26.1) | 34 (30.4) | 64 (28.2) |
   >9 | 10 (8.7) | 7 (6.3) | 17 (7.5) |
SOFA Score | |||
   N | 57 | 58 | 115 |
   Mean (SD) | 6.0 (2.70) | 5.5 (2.39) | 5.8 (2.55) |
   Median | 6.0 | 5.0 | 5.0 |
   Range | (0; 14) | (2; 12) | (0; 14) |
Charlson Comorbidity Index | |||
   N | 114 | 112 | 226 |
   Mean (SD) | 3.0 (2.72) | 2.8 (2.45) | 2.9 (2.59) |
   Median | 3.0 | 3.0 | 3.0 |
   Range | (0; 14) | (0; 9) | (0; 14) |
PaO 2 /FiO 2 , n (%) | Â | Â | Â |
   N | 115 | 112 | 227 |
≤250 | 67 (58.3) | 61 (54.5) | 128 (56.4) |
   >250 | 48 (41.7) | 51 (45.5) | 99 (43.6) |
Bacteremia, n (%) | Â | Â | Â |
   N | 115 | 112 | 227 |
   No | 109 (94.8) | 107 (95.5) | 216 (95.2) |
   Yes | 6 (5.2) | 5 (4.5) | 11 (4.8) |
Creatinine clearance, n (%) | |||
   N | 115 | 112 | 227 |
   Supra normal (≥150 ml/min) | 23 (20.0) | 34 (30.4) | 57 (25.1) |
   Normal (≥80 to <150 ml/min) | 46 (40.0) | 44 (39.3) | 90 (39.6) |
   Mild renal failure (>50 to <80 ml/min) | 33 (28.7) | 26 (23.2) | 59 (26.0) |
   Moderate renal failure (>30 to ≤50 ml/min) | 7 (6.1) | 4 (3.6) | 11 (4.8) |
   Severe renal failure (≤30 ml/min) | 6 (5.2) | 4 (3.6) | 10 (4.4) |
Failed antibiotic treatment for VAP, n (%) | |||
   N | 69 | 78 | 147 |
   No | 59 (85.5) | 67 (85.9) | 126 (85.7) |
   Yes | 10 (14.5) | 11 (14.1) | 21 (14.3) |
Prior antibacterial therapy usage (hours), n (%) | |||
   N | 115 | 112 | 227 |
   <24 | 28 (24.3) | 35 (31.3) | 63 (27.8) |
≥24 to <48 | 10 (8.7) | 10 (8.9) | 20 (8.8) |
≥48 to ≤72 | 9 (7.8) | 5 (4.5) | 14 (6.2) |
   >72 | 68 (59.1) | 62 (55.4) | 130 (57.3) |
Adjunctive therapy, n (%) | |||
   N | 115 | 112 | 227 |
   No | 75 (65.2) | 79 (70.5) | 154 (67.8) |
   Yes |  |  |  |
≤72 Hrs | 32 (27.8) | 25 (22.3) | 57 (25.1) |
   >72 Hrs | 8 (7.0) | 8 (7.1) | 16 (7.0) |
Adjunctive aminoglycoside, n (%) | |||
   N | 40 | 33 | 73 |
   No | 19 (47.5) | 20 (60.6) | 39 (53.4) |
   Yes |  |  |  |
   ≤72 Hrs | 20 (50.0) | 12 (36.4) | 32 (43.8) |
   >72 Hrs | 1 (2.5) | 1 (3.0) | 2 (2.7) |
Adjunctive vancomycin/linezolid, n (%) | Â | Â | Â |
   N | 40 | 33 | 73 |
   No | 14 (35.0) | 9 (27.3) | 23 (31.5) |
   Yes |  |  |  |
≤72 hrs | 20 (50.0) | 18 (54.5) | 38 (52.1) |
   >72 hrs | 6 (15.0) | 6 (18.2) | 12 (16.4) |