TABLE 2.
Microbiological outcome at TOC (primary efficacy endpoint)a
| Population | Treatment | No. of patients | No. (%) of patients with eradication | 95% CI for eradication (%) | No. (%) of patients with noneradication | No. (%) of patients with indeterminate outcomeb |
|---|---|---|---|---|---|---|
| MITT | Plazomicin at 10 mg/kg | 12 | 6 (50.0) | 21.1–78.9 | 1 (8.3) | 5 (41.7) |
| Plazomicin at 15 mg/kg | 51 | 31 (60.8) | 46.1–74.2 | 5 (9.8) | 15 (29.4) | |
| Levofloxacin at 750 mg | 29 | 17 (58.6) | 38.9–76.5 | 4 (13.8) | 8 (27.6) | |
| ME | Plazomicin at 10 mg/kg | 7 | 6 (85.7) | 42.1–99.6 | 1 (14.3) | – |
| Plazomicin at 15 mg/kg | 35 | 31 (88.6) | 73.3–96.8 | 4 (11.4) | – | |
| Levofloxacin at 750 mg | 21 | 17 (81.0) | 58.1–94.6 | 4 (19.0) | – |
a
The difference in microbiological eradication rates between the group receiving plazomicin at 15 mg/kg and the group receiving levofloxacin was 2.2% (95% CI, −22.9 to 27.2%) for the MITT population and 7.6% (95% CI, −16.0 to 31.3%) for the ME population. The 95% CI for the difference was based on a normal approximation with a continuity correction.
b
–, patients with missing or indeterminate outcome data were excluded from the ME population.