Table 4.
Efficacy outcomes in ASPECT-NP participants who were failing prior antibacterial therapy
| Endpoint | C/T n/N (%) | MEM n/N (%) | % Difference (95% CI)a |
|---|---|---|---|
| 28-day all-cause mortality (ITT)b | 12/53 (22.6) | 18/40 (45.0) | 22.4 (3.1 to 40.1) |
| 28-day all-cause mortality (mITT)b | 7/39 (17.9) | 11/24 (45.8) | 27.9 (4.7 to 49.0) |
| Clinical cure at TOC (ITT)b | 26/53 (49.1) | 15/40 (37.5) | 11.6 (− 8.6 to 30.2) |
| Clinical cure at TOC (CE)c | 21/33 (63.6) | 9/20 (45.0) | 18.6 (− 8.2 to 42.5) |
| Microbiologic eradication at TOC (mITT)b,d | 26/39 (66.7) | 16/24 (66.7) | 0.0 (− 22.0 to 23.7) |
| Microbiologic eradication at TOC (ME)b,d | 10/17 (58.8) | 4/7 (57.1) | 1.7 (− 33.7 to 39.3) |
CE Clinically evaluable, C/T Ceftolozane/tazobactam, ITT Intention-to-treat, ME Microbiologically evaluable, MEM Meropenem, mITT Microbiological intention-to-treat, TOC Test of cure, n Number of study participants meeting the criteria for each assessment, N Number of study participants in each subgroup of the respective analysis population
aUnstratified Newcombe CIs; positive differences are in favor of ceftolozane/tazobactam, negative differences are in favor of meropenem
bParticipants with missing/indeterminate data were reported as deceased or as failures, depending on the endpoint
cData reported as observed, i.e., participants with missing/indeterminate responses were excluded from analysis
dPer-participant microbiologic eradication