TABLE 5.
Summary statistics of efficacy response rates and day 1 AUC(0–24)/MIC ratios, by MICsa
| Endpoint MIC (μg/ml) | No. of subjects (%) exhibiting |
Mean day 1 fAUC(0–24)/MIC (h) (SD) | Median day 1 fAUC(0–24)/MIC (h) | Minimum, maximum day 1 fAUC(0–24)/MIC (h) | No. of subjects | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Early clinical response at 48 to 72 h (≥20% decrease in lesion area) in the ITT population |
Clinical response at the PTE in the ITT population |
Clinical response at the PTE in the CE-PTE population |
Microbiologic response at the EOT in the ME population |
Microbiologic response at the PTE in the ME population |
||||||||||
| No | Yes | No | Yes | No | Yes | No | Yes | No | Yes | |||||
| ≤0.06 | 3 (33.3) | 6 (66.7) | 0 (0.0) | 9 (100.0) | 0 (0.0) | 8 (100.0) | 0 (0.0) | 7 (100.0) | 0 (0.0) | 7 (100.0) | 147.97 (86.92) | 159.56 | 7.23, 251.89 | 9 |
| 0.12 | 6 (18.2) | 27 (81.8) | 9 (27.3) | 24 (72.7) | 3 (11.5) | 23 (88.5) | 1 (4.5) | 21 (95.5) | 2 (9.1) | 20 (90.9) | 32.24 (7.24) | 31.63 | 20.51, 48.55 | 33 |
| 0.25 | 39 (14.7) | 227 (85.3) | 25 (9.4) | 241 (90.6) | 13 (5.3) | 233 (94.7) | 8 (3.4) | 227 (96.6) | 12 (5.1) | 223 (94.9) | 14.76 (4.05) | 14.84 | 1.91, 27.24 | 266 |
| 0.5 | 9 (13.0) | 60 (87.0) | 6 (8.7) | 63 (91.3) | 2 (3.3) | 58 (96.7) | 3 (5.1) | 56 (94.9) | 2 (3.4) | 57 (96.6) | 7.89 (1.78) | 7.78 | 3.02, 12.26 | 69 |
| Overall | 57 (15.1) | 320 (84.9) | 40 (10.6) | 337 (89.4) | 18 (5.3) | 322 (94.7) | 12 (3.7) | 311 (96.3) | 16 (5.0) | 307 (95.0) | 18.21 (25.01) | 14.36 | 1.91, 251.89 | 377 |
a
AUC(0–24), area under the concentration-time curve from time zero to 24 h; CE-PTE, clinically evaluable at the PTE; EOT, end-of-therapy; ITT, intent-to-treat; ME, microbiologically evaluable; PTE, posttherapy evaluation. MIC data reflect actual observations from patients enrolled in phase 3 studies, while AUCs were model derived for the same patients.