Table 2 Baseline demographics of patients included in the pharmacokinetics, safety, and clinical efficacy analyses
Baseline demographics | All patients (n = 512) | Patients in clinical efficacy population (n = 76) | ||||
|---|---|---|---|---|---|---|
Conventional high loading dose regimen (n = 363) | Enhanced high loading dose regimen (n = 149) | P value | Conventional high loading dose regimen (n = 53) | Enhanced high loading dose regimen (n = 23) | P value | |
Sex male (%) | 220 (60.6%) | 98 (65.8%) | 0.274 | 33 (62.3%) | 19 (82.6%) | 0.109 |
Age (years) | 64.9 ± 15.8 | 67.2 ± 14.2 | 0.127 | 69.1 ± 13.1 | 70.3 ± 14.8 | 0.737 |
Body weight (kg) | 55.5 ± 11.1 | 55.7 ± 12.0 | 0.819 | 53.0 ± 10.3 | 55.0 ± 13.8 | 0.483 |
Body mass index | 21.3 ± 4.0 | 21.5 ± 4.5 | 0.787 | 20.8 ± 3.7 | 20.2 ± 4.9 | 0.528 |
Serum albumin (g/dL) | 2.6 ± 0.6 | 2.5 ± 0.6 | 0.174 | 2.5 ± 0.5 | 2.3 ± 0.5 | 0.076 |
Estimated glomerular filtration rate (mL/min/1.73 m2) | 69.5 ± 37.7 | 63.0 ± 33.1 | 0.065 | 70.5 ± 38.0 | 62.7 ± 35.4 | 0.408 |
≥60 mL/min/1.73 m2 (Normal renal function) | 211 (58.1%) | 82 (55.0%) | 0.520 | 33 (62.3%) | 13 (56.5%) | 0.638 |
Type of infection | ||||||
Bacteremia | 107 (29.5%) | 48 (32.2%) | 0.540 | 15 (28.3%) | 7 (30.4%) | 0.851 |
Infectious endocarditis | 3 (0.8%) | 4 (2.7%) | 0.202 | 0 (0.0%) | 0 (0.0%) | – |
Pneumonia (VAP in clinical efficacy population) | 59 (16.3%) | 21 (14.1%) | 0.541 | 35 (66.0%) | 15 (65.2%) | 0.945 |
Osteomyelitis and arthritis | 23 (6.3%) | 13 (8.7%) | 0.337 | 6 (11.3%) | 3 (13.0%) | 1.000 |
Central nervous system infections | 0 (0.0%) | 1 (0.7%) | 0.291 | 0 (0.0%) | 1 (4.3%) | 0.303 |
Intraabdominal infections | 61 (16.8%) | 24 (16.1%) | 0.847 | – | – | – |
Skin & soft tissue infections | 25 (6.9%) | 10 (6.7%) | 0.943 | – | – | – |
Urinary tract infections | 11 (3.0%) | 2 (1.3%) | 0.364 | – | – | – |
Sinusitis | 2 (0.6%) | 0 (0.0%) | 1.000 | – | – | – |
Mediastinitis | 0 (0.0%) | 0 (0.0%) | – | – | – | – |
Unknown (empiric therapy) | 90 (24.8%) | 41 (27.5%) | 0.521 | – | – | – |
Isolated Gram-positive organisms | ||||||
MRSA | 107 (43.9%) | 49 (43.8%) | 0.986 | 53 (100%) | 23 (100%) | – |
MSSA | 18 (7.4%) | 9 (8.0%) | 0.827 | – | – | – |
MR-CNS | 50 (20.5%) | 24 (21.4%) | 0.840 | – | – | – |
MS-CNS | 7 (2.9%) | 1 (0.9%) | 0.444 | – | – | – |
Enterococcus faecalis | 16 (6.6%) | 7 (6.3%) | 0.913 | – | – | – |
Enterococcus faecium | 41 (16.8%) | 23 (20.5%) | 0.394 | – | – | – |
Other Enterococcus sp | 10 (4.1%) | 0 (0.0%) | 0.034 | – | – | – |
Streptococcus sp | 9 (3.7%) | 4 (3.6%) | 1.000 | – | – | – |
Gram-positive rod | 7 (2.9%) | 2 (1.8%) | 0.725 | – | – | – |