TABLE 2.
Clinical and microbiological responses at the test-of-cure visit by β-lactamase status (mMITT population)
| Patient subgroup | Cure rate at test of cure |
Comparison between groups |
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|---|---|---|---|---|---|---|---|---|
| CAZ-AVI (n = 149) |
BAT (n = 146) |
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| No. of patients | No. (%) of patients with clinical curea | No. (%) of patients with microbiological cureb | No. of patients | No. (%) of patients with clinical curea | No. (%) of patients with microbiological cureb | % difference of clinical cure ratec | % difference of microbiological cure rated | |
| All | 149 | 135 (90.6) | 123 (82.6) | 146 | 133 (91.1) | 92 (63.0) | −0.5 | 19.6 |
| Enterobacteriaceaee | 136 | 124 (91.2) | 112 (82.4) | 141 | 128 (90.8) | 89 (63.1) | +0.4 | +19.3 |
| CTX-Mf | 107 | 99 (92.5) | 91 (85.0) | 112 | 104 (92.9) | 72 (64.3) | −0.4 | +20.7 |
| AmpC/ESBLg | 20 | 16 (80.0) | 16 (80.0) | 19 | 17 (89.5) | 11 (57.9) | −9.5 | +22.1 |
| Carbapenemase/ESBL | 8h | 8 (100.0) | 4 (50.0) | 6i | 4 (66.7) | 3 (50.0) | +33.3 | 0.0 |
| P. aeruginosa | 13j | 11 (84.6) | 11 (84.6) | 5 | 5 (100.0) | 3 (60.0) | −15.4 | +24.6 |
Percentages for clinical cure rates are calculated as m/n, where m is defined by the number of patients with a favorable clinical response at the test-of-cure visit and n is represented by the combined number of patients with clinical cure, clinical failure, and an indeterminate outcome.
Percentages for microbiological cure rates are calculated as m/n, where m is defined by the number of patients with a favorable microbiological response at the test-of-cure visit and n is represented by the combined number of patients with microbiological cure, failure, and an indeterminate outcome.
The difference of the favorable clinical cure rate is calculated as CAZ-AVI treatment group minus BAT treatment group.
Difference of favorable microbiological responses is calculated as CAZ-AVI treatment group minus BAT treatment group.
Two and three patients had polymicrobial infections in the CAZ-AVI and BAT groups, respectively.
Includes patients with isolates carrying CTX-M-encoding genes with or without non-ESBL and/or ESBL genes (OXA-1, OXA-10, OXA-9, SHV-11, SHV-12, SHV-5, SHV-1, and TEM-1) (Table 1).
Includes patients with isolates with documented overexpression of the intrinsic chromosomal AmpC gene, carrying plasmid AmpC, and/or with multiple non-ESBL and/or ESBL genes (Table 1).
Includes KPC (3 isolates)-, VIM (1)-, NDM (2)-, and OXA-48 (2)-encoding genes.
Includes KPC (3 isolates)-, VIM (1)-, NDM (1)-, and OXA-48 (1)-encoding genes.
One patient had a polymicrobial cUTI (P. aeruginosa and P. stuartii) at the baseline visit.