Table 2.
Clinical cure and favorable microbiological response rates at TOC in the bacteremia subset and overall set (Gram-negative extended microbiologically evaluable population)
| Bacteremia subset | Overall set | |||||
|---|---|---|---|---|---|---|
| Ceftazidime-avibactam, n/N (%) |
Comparator, n/N (%) |
Difference (%) (95% CI)a |
Ceftazidime-avibactam, n/N (%) |
Comparator, n/N (%) |
Difference (%) (95% CI)a |
|
| Clinical cure | ||||||
| cIAI | 9/11 (81.8) | 9/10 (90.0) | − 8.2 (− 41.16, 27.12) | 349/378 (92.3) | 396/418 (94.7) | − 2.4 (− 6.03, 1.02) |
| cUTI/pyelonephritis | 28/28 (100.0) | 25/29 (86.2) | 13.8 (0.71, 30.74) | 409/423 (96.7) | 418/435 (96.1) | 0.6 (− 2.01, 3.24) |
| NP/VAP | 10/15 (66.7) | 5/8 (62.5) | 4.2 (− 33.32, 43.99) | 96/125 (76.8) | 103/131 (78.6) | − 1.8 (− 12.13, 8.41) |
| All indications | 47/54 (87.0) | 39/47 (83.0) | 4.1 (− 10.21, 19.09) | 854/926 (92.2) | 917/984 (93.2) | − 1.0 (− 3.34, 1.37) |
| Favorable microbiological response | ||||||
| All Gram-negative pathogens | ||||||
| cIAI | 9/11 (81.8) | 9/10 (90.0) | − 8.2 (− 41.16, 27.12) | 349/378 (92.3) | 396/418 (94.7) | − 2.4 (− 6.03, 1.02) |
| cUTI/pyelonephritis | 26/28 (92.9) | 20/29 (69.0) | 23.9 (3.58, 43.73) | 357/423 (84.4) | 320/435 (73.6) | 10.8 (5.41, 16.24) |
| NP/VAP | 8/15 (53.3) | 3/8 (37.5) | 15.8 (− 26.35, 51.79) | 80/125 (64.0) | 89/131 (67.9) | − 3.9 (− 15.49, 7.66) |
| All indications | 43/54 (79.6) | 32/47 (68.1) | 11.5 (− 5.65, 28.72) | 786/926 (84.9) | 805/984 (81.8) | 3.1 (− 0.28, 6.41) |
| Ceftazidime-resistant pathogensb | ||||||
| All indications | 6/11 (54.5) | 9/19 (47.4) | 7.2 (− 28.72, 41.08) | 237/288 (82.3) | 226/310 (72.9) | 9.4 (2.71, 16.00) |
CI confidence interval, cIAI complicated intra-abdominal infection, cUTI complicated urinary tract infection, MIC minimum inhibitory concentration, NP nosocomial pneumonia, TOC test of cure, VAP ventilator-associated pneumonia
aFor clinical and microbiological response, this difference represents the difference in rates from the ceftazidime-avibactam treatment group minus rates in the comparator group. The CI for the difference was calculated using the unstratified Miettinen and Nurminen method
bResistance to ceftazidime was defined as minimum inhibitory concentration ≥ 8 µg/l for Enterobacterales and ≥ 16 µg/l for Pseudomonas aeruginosa or disk diffusion diameter ≤ 20 mm for Enterobacterales and ≤ 17 mm for P. aeruginosa