Table 3.
Primary and secondary efficacy outcomes in ASPECT-NP participants with ventilated hospital-acquired bacterial pneumonia by treatment arm
| Endpoint | C/T n/N (%) |
Meropenem n/N (%) |
% Difference (95% CI)** |
|---|---|---|---|
| 28-day all-cause mortality (ITT)* | 24/99 (24.2%) | 40/108 (37.0%) | 12.8% (0.2, 24.8) |
| All LRT pathogens susceptible to randomized study drug‡ | 7/38 (18.4%) | 20/55 (36.4%) | 17.9% (− 0.9, 34.0) |
| ≥ 1 LRT pathogen non-susceptible to randomized study drug‡ | 10/37 (27.0%) | 11/26 (42.3%) | 15.3% (− 7.9, 37.3) |
| 28-day all-cause mortality (mITT)* | 10/55 (18.2%) | 26/71 (36.6%) | 18.4% (2.5, 32.5) |
| Monomicrobial | 5/33 (15.2%) | 16/40 (40.0%) | 24.8% (4.0, 42.4) |
| Polymicrobial | 5/22 (22.7%) | 10/31 (32.3%) | 9.5% (− 15.3, 31.2) |
| Clinical cure at TOC (ITT)* | 50/99 (50.5%) | 48/108 (44.4%) | 6.1% (− 7.4, 19.3) |
| Clinical cure at TOC (CE)§ | 34/59 (57.6%) | 32/49 (65.3%) | − 7.7% (− 25.0, 10.6) |
| Microbiologic eradication at TOC (mITT)*,¶ | 43/55 (78.2%) | 44/71 (62.0%) | 16.2% (− 0.1, 30.8) |
| Microbiologic eradication at TOC (ME)*,¶ | 15/21 (71.4%) | 16/25 (64.0%) | 7.4% (− 19.1, 31.9) |
CE, clinically evaluable. CI, confidence interval. C/T, ceftolozane/tazobactam. ITT, intent-to-treat. ME, microbiologically evaluable. mITT, microbiological intent-to-treat. TOC, test-of-cure
*Patients with missing/indeterminate data are reported as deceased or as failures, depending on the endpoint
‡Not all ITT patients had confirmed baseline pathogens and susceptibility data available
§Data reported as observed, i.e., patients with missing/indeterminate responses excluded from analysis
¶Per-patient microbiologic eradication
**Unstratified Newcombe CIs; positive differences are in favor of ceftolozane/tazobactam, negative differences are in favor of meropenem