Table 2.
Baseline lower respiratory tract pathogens (with a total incidence of ≥ 5%) in ASPECT-NP participants with ventilated hospital-acquired bacterial pneumonia (ITT population and mITT population)
| ITT population (primary efficacy population)* | |||
|---|---|---|---|
| LRT pathogen, n (%) | C/T (N = 75) |
Meropenem (N = 84) |
Total (N = 159) |
| Gram-negative | 74 (98.7) | 80 (95.2) | 154 (96.9) |
| Enterobacterales | 47 (62.7) | 61 (72.6) | 108 (67.9) |
| ESBL-positive Enterobacterales | 27 (36.0) | 25 (29.8) | 52 (32.7) |
| Klebsiella pneumoniae | 32 (42.7) | 36 (42.9) | 68 (42.8) |
| Escherichia coli | 10 (13.3) | 15 (17.9) | 25 (15.7) |
| Enterobacter cloacae | 4 (5.3) | 5 (6.0) | 9 (5.7) |
| Proteus mirabilis | 1 (1.3) | 7 (8.3) | 8 (5.0) |
| Pseudomonas aeruginosa | 17 (22.7) | 17 (20.2) | 34 (21.4) |
| Acinetobacter baumannii | 19 (25.3) | 17 (20.2) | 36 (22.6) |
| Haemophilus influenzae | 5 (6.7) | 4 (4.8) | 9 (5.7) |
| Streptococci‡ | 3 (4.0) | 14 (16.7) | 17 (10.7) |
| mITT population (secondary efficacy population)† | |||
|---|---|---|---|
| LRT pathogen, n (%) | C/T (N = 55) |
Meropenem (N = 71) |
Total (N = 126) |
| Gram-negative | 54 (98.2) | 67 (94.4) | 121 (96.0) |
| Enterobacterales | 37 (67.3) | 55 (77.5) | 92 (73.0) |
| ESBL-positive Enterobacterales | 17 (30.9) | 23 (32.4) | 40 (31.7) |
| Klebsiella pneumoniae | 21 (38.2) | 30 (42.3) | 51 (40.5) |
| Escherichia coli | 10 (18.2) | 15 (21.1) | 25 (19.8) |
| Enterobacter cloacae | 4 (7.3) | 5 (7.0) | 9 (7.1) |
| Proteus mirabilis | 1 (1.8) | 6 (8.5) | 7 (5.6) |
| Pseudomonas aeruginosa | 12 (21.8) | 15 (21.1) | 27 (21.4) |
| Acinetobacter baumannii | 5 (9.1) | 6 (8.5) | 11 (8.7) |
| Haemophilus influenzae | 5 (9.1) | 4 (5.6) | 9 (7.1) |
| Streptococci‡ | 3 (5.5) | 10 (14.1) | 13 (10.3) |
C/T, ceftolozane/tazobactam. ESBL, extended-spectrum β-lactamase. ITT, intent-to-treat. LRT, lower respiratory tract. mITT, microbiologic intent-to-treat. n, number of study participants with the specific pathogen. N, number of study participants in the specific treatment arm and analysis population with ≥ 1 baseline LRT
*Study participants were eligible for inclusion into the ITT population regardless of whether they had a baseline pathogen, the type of pathogen, and pathogen susceptibility
†Study participants were eligible for inclusion into the mITT population only if baseline LRT cultures yielded ≥ 1 gram-negative or streptococcal respiratory pathogen that was susceptible to ≥ 1 study drug
‡Since causative gram-positive LRT pathogens other than streptococci are frequently not susceptible to either study drug, microbiology data on non-streptococcal gram-positive pathogens were not captured