TABLE 3.
Summary statistics of exposure measurements and primary and key secondary efficacy outcomes by the baseline pathogena
| Variable | Statistic |
Enterobacteralesb (n = 154) |
Pseudomonas aeruginosab (n = 43) |
Overallb (N = 191) |
|---|---|---|---|---|
| %ƒT>CT >1 μg/mL for tazobactam | Mean (SD) | 76.1 (24.6) | 79.7 (23.1) | 76.9 (24.3) |
| Median (min–max) | 87.2 (28.0–99.0) | 94.4 (22.8–99.0) | 87.2 (22.8–99.0) | |
| %ƒT>MIC for ceftolozane | Mean (SD) | 84.3 (32.8) | 94.8 (16.1) | 86.6 (30.3) |
| Median (min–max) | 99.0 (0.0–99.0) | 99.0 (0.0–99.0) | 99.0 (0.0–99.0) | |
| Ceftolozane/tazobactam MIC, μg/mL | Mean (SD) | 23.1 (58.8) | 8.8 (39.2) | 20.0 (55.4) |
| Median (min–max) | 0.5 (0.1–256.0) | 1.0 (0.3–256.0) | 0.5 (0.1–256.0) | |
| 28-day all-cause mortality,c n (%) | Death | 20 (13.0) | 10 (23.3) | 30 (15.2) |
| Clinical cure at TOC,d n (%) | Cure | 104 (67.5) | 28 (65.1) | 132 (67.0) |
%fT>CT >1 μg/mL, percentage of time the threshold concentration of tazobactam exceeded 1 μg/mL; %fT>MIC, percentage of time the concentration of free ceftolozane in plasma exceeded the MIC that was determined in the presence of tazobactam; EOT, end of treatment; max, maximum; min, minimum; TOC, test of cure.
The analysis set presented in this table is a subset of the exposure–efficacy analysis set. Six participants had two baseline pathogens with the same highest baseline MIC value and were included in both the Enterobacterales and P. aeruginosa groups.
Mortality was assessed on days 14 and 28; the 28-day all-cause mortality endpoint accounted for deaths on or before day 28.
Clinical response assessments were performed at the EOT, TOC, and late follow-up visits. Determination of clinical response was based on an overall assessment of clinical status based on signs, symptoms, and available laboratory data. Clinical responses at EOT and TOC visits were classified as cure, failure, or indeterminate. “Clinical cure” was a favorable clinical response.