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) |