TABLE 4.
Summary of favorable responses at the TOC assessment among the ME patients enrolled in the cUTI and cIAI phase 2 trials for ceftazidime-avibactam
| Trial | Organism(s) | Categorya | Result for treatment arm by no. of patients with favorable response/total (%)b |
|
|---|---|---|---|---|
| Ceftazidime-avibactam | Carbapenem | |||
| cIAI and cUTI combined | Enterobacteriaceaec | Screen negative | 42/45d (93.3) | 60/66 (90.9) |
| Screen positive | 30/35 (85.7) | 24/30e (80.0) | ||
| CTX-M-15 | 22/26 (84.6) | 19/24 (79.2) | ||
| CTX-M-15 alone | 8/8 (100.0) | 6/10 (60.0) | ||
| CTX-M-15 + additional ESBLs | 14/18 (77.8) | 17/19 (89.5) | ||
| Other enzymes | 8/9 (88.9) | 5/6 (83.3) | ||
| NF-GNBf | All | 6/7g (85.7) | 9/9h (100.0) | |
| cIAI | Enterobacteriaceae | Screen negative | 28/31 (90.3) | 40/44i (90.9) |
| Screen positive | 22/24 (91.7) | 17/18i (94.4) | ||
| cUTI | Allj | Screen negative | 15/16k (93.8) | 20/22l (90.9) |
| Screen positive | 8/11 (72.7) | 8/13 (61.5) | ||
| E. coli | ST131 | 6/8 (75.0) | 2/3 (66.7) | |
| Non-ST131 | 15/16 (93.8) | 26/30 (86.7) | ||
Screen negative, isolates that did not meet the MIC-based screening criteria; screen positive, isolates that met the screening criteria (i.e., ceftriaxone and/or ceftazidime MICs of ≥2 μg/ml and NF-GNB with ceftazidime MICs of ≥16 μg/ml, and Enterobacteriaceae and NF-GNB isolates exhibiting imipenem and meropenem MICs of ≥2 and ≥16 μg/ml, respectively).
Results are expressed as the number of patients with favorable responses/total number of patients in each category (percentage) and represent the ceftazidime-avibactam or imipenem-cilastatin arms for cUTI and the ceftazidime-avibactam plus metronidazole or meropenem arms for cIAI.
Patients from whom Enterobacteriaceae pathogens were recovered at the baseline visit.
Includes one patient with a polymicrobial infection caused by E. coli and C. koseri at the baseline visit.
Includes one patient with a polymicrobial infection caused by aerobic Gram-negative pathogens (E. coli and K. pneumoniae).
Patients infected with NF-GNB pathogens with or without concomitant culture of aerobic Enterobacteriaceae isolates at the baseline visit.
Includes six patients with polymicrobial infections (4 with P. aeruginosa-E. coli, 1 with P. aeruginosa-A. baumannii, and 1 with P. stutzeri-E. coli).
Includes five patients with polymicrobial infections (2 with P. aeruginosa-E. coli, 1 with E. coli-A. baumannii, and 1 with P. fluorescens-E. coli-K. pneumoniae).
Includes one patient with a polymicrobial infection (E. coli-K. pneumoniae) with β-lactamase-producing pathogens and four patients with polymicrobial infections (2 with E. coli-K. pneumoniae and 2 with E. coli-K. oxytoca) with MIC-based screen-negative pathogens.
Patients infected with Enterobacteriaceae pathogens, unless otherwise indicated.
Includes two patients with polymicrobial infection (1 with E. coli-P. aeruginosa and 1 with E. coli-C. koseri) and one patient infected with a P. aeruginosa isolate at baseline.
Includes two patients with polymicrobial infections (1 with E. coli-P. aeruginosa and 1 with E. coli-P. mirabilis) at baseline.