TABLE 2.
Subject characteristics
| Characteristic | Median (continuous variables) or no. (categorical variables) | Range (continuous variables) or % (categorical variable) |
|---|---|---|
| Continuous variables | ||
| Body weight (kg) | 75.1 | 48.2-152.8 |
| Body surface area (m2) | 1.9 | 1.5-2.8 |
| Age (yr) | 51 | 18-93 |
| Body temp on day of pharmacokinetic study (°C)a | 37.2 | 36.1-40.1 |
| Baseline serum albumin (g/dl)b | 4.2 | 2.8-5.0 |
| Baseline alkaline phosphatase (IU/liter) | 81 | 27-730 |
| Baseline ALT (IU/liter) | 21 | 3-176 |
| Baseline AST (IU/liter) | 21 | 4-292 |
| Baseline total bilirubin (mg/dl) | 0.5 | 0.2-15.7 |
| Baseline BUN (mg/dl) | 15 | 4-115 |
| Baseline blood glucose (mg/dl) | 98 | 41-382 |
| Baseline serum creatinine (mg/dl)c | 1.0 | 0.2-18.2 |
| Baseline creatinine clearance (ml/min)d,e | 91.2 | 14.0-150.0 |
| Average serum creatinine (mg/dl)c,f | 1.0 | 0.2-15.5 |
| Average creatinine clearance (ml/min)d,g | 92.2 | 14.0-150.0 |
| Categorical variables | ||
| Study (phase 1, phase 2/3) | 153, 129 | 54, 46 |
| Sex (male, female) | 166, 116 | 59, 41 |
| Race (Caucasian, African-American, other) | 163, 51, 68 | 58, 18, 24 |
| Dialysis (yes, no) | 21, 26 | 7, 93 |
| Renal function 5 categories (≥80 ml/min, ≥50 to <80 ml/min, ≥30 to <50 ml/min, <30 ml/min, on dialysis) | 165, 64, 24, 8, 21 | 59, 23, 9, 3, 7 |
| Renal function 4 categories (≥80 mL/min, >40 to <80 ml/min, ≤40 ml/min, on dialysis) | 165, 80, 16, 21 | 59, 28, 6, 7 |
| Elevated baseline BUN (>ULN = 25 mg/dl) | 52 | 18 |
| Elevated baseline serum creatinine (>ULN = 1.4 mg/dl) | 40 | 14 |
| Elevated baseline blood glucose (>ULN = 109 mg/dl) | 55 | 20 |
| Hyperthermic (≥38°C) | 14 | 14 |
| Has diabetes | 47 | 17 |
| Has hypertension | 52 | 18 |
| Has congestive heart failure | 19 | 7 |
| Has fluid accumulation (edema or ascites) | 22 | 8 |
| Has gram-positive bacterial infection | 129 | 46 |
| Taking concomitant aztreonam | 17 | 6 |
| Taking concomitant metronidazole | 0 | 0 |
| Taking concomitant medication that is secreted in the renal tubule (including probenecid) | 93 | 33 |
| Taking concomitant medication that is >95% bound to albumin | 64 | 23 |
a
On day of blood samples obtained for pharmacokinetics (n = 100). Data are missing for all phase 1 studies and for 29 subjects in phase 2/3 studies.
b
n = 164 (data are missing for five phase 2/3 studies).
c
n = 282.
d
n = 261 (excludes subjects on dialysis).
e
Includes 38 subjects (14.6%) for whom the estimated creatinine clearance was set to 150 ml/min.
f
Average of minimum and maximum values recorded over the period of the pharmacokinetic study.
g
Includes 34 subjects (13.0%) for whom the estimated creatinine clearance was set to 150 ml/min.