You are viewing the site in preview mode
Skip to main content
|
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
|
–
|
–
|
–
|
- Age, body weight, serum albumin and estimated glomerular filtration rate are expressed as the mean ± S.D.
- VAP ventilator associated pneumonia, MRSA methicillin-resistant Staphylococcus aureus, MSSA methicillin-sensitive Staphylococcus aureus, MR-CNS methicillin-resistant coagulase-negative Staphylococci, MS-CNS methicillin-sensitive coagulase-negative Staphylococci
