TABLE 2.
Summary statistics of exposure estimates and PK-PD measures from the PK-PD efficacy analysis population, stratified by microbiological response
| Exposure or PK-PD measure | Microbiological response
|
||
|---|---|---|---|
| Success (n = 47) | Failure (n = 8)a | All patients (n = 55) | |
| AUC0-24 (μg · h/ml) | |||
| Mean (SD) | 454.48 (195.49) | 480.78 (408.29) | 458.30 (232.92) |
| Median (range) | 405.69 (144.54-883.27) | 337.13 (244.78-478.49) | 399.07 (144.54-1478.49) |
| AUC0-24/MIC | |||
| Mean (SD) | 219.69 (121.74) | 217.36 (215.06) | 219.35 (136.46) |
| Median (range) | 184.37 (72.27-655.26) | 150.05 (76.90-739.25) | 181.98 (72.27-739.25) |
| Cmax (μg/ml) | |||
| Mean (SD) | 82.13 (24.73) | 81.09 (39.13) | 81.98 (26.83) |
| Median (range) | 81.69 (38.87-130.20) | 71.07 (48.65-172.08) | 79.48 (38.87-172.08) |
| Cmax/MIC | |||
| Mean (SD) | 39.78 (17.21) | 36.31 (22.51) | 39.27 (17.87) |
| Median (range) | 38.86 (15.32-97.09) | 30.71 (15.25-86.04) | 37.94 (15.25-97.09) |
| % Time > MIC | |||
| Mean (SD) | 96.21 (11.04) | 96.35 (8.97) | 96.23 (10.69) |
| Median (range) | 99.58 (38.75-99.58) | 99.58 (74.17-99.58) | 99.58 (38.75-99.58) |
| Free-drug % time > MIC | |||
| Mean (SD) | 28.26 (16.74) | 28.02 (29.26) | 28.23 (18.70) |
| Median (range) | 23.75 (9.17-84.58) | 19.79 (8.75-99.17) | 23.33 (8.75-99.17) |
a
When contrasting patients with microbiological success versus failure, larger mean differences between the two groups with respect to exposure and PK-PD measures were observed when one patient, considered a medical outlier, was excluded. Although having the highest exposure and PK-PD measure (except for Cmax/MIC, which was the second highest), this patient was a microbiological failure. When excluded, the mean (SD) and median (range) free-drug % time > MIC were 17.86 (5.89) and 18.33 (8.75, 26.25), respectively, for patients with microbiological failure (n = 7).