Table 5.
Overall Response at Test of Cure by Resistance Class: Microbiologic Modified Intent-to-Treat Population
| Outcome | Sulopenem, n/N (%) |
Ertapenem, n/N (%) |
Difference, % (95% Confidence Interval) |
|---|---|---|---|
| Overall success at test of cure (primary end point) | 301/444 (67.8) | 325/440 (73.9) | −6.1 (−12.0 to −.1) |
| ESBL-negative | 219/329 (66.6) | 238/311 (76.5) | −10.0 (−16.9 to −3.0) |
| ȃQuinolone-resistant | 47/69 (68.1) | 51/79 (64.6) | 3.6 (−12.0 to 18.6) |
| ȃQuinolone-susceptible | 172/260 (66.2) | 187/232 (80.6) | −14.4 (−22.0 to −6.7) |
| ESBL-positive | 79/110 (71.8) | 85/125 (68.0) | 3.8 (−7.9 to 15.5) |
| ȃQuinolone-resistant | 64/92 (69.6) | 64/99 (64.6) | 4.9 (−8.5 to 18.1) |
| ȃQuinolone-susceptible | 15/18 (83.3) | 21/26 (80.8) | 2.6 (−23.0 to 25.3) |
| Quinolone-resistant | 112/162 (69.1) | 116/179 (64.8) | 4.3 (−5.6 to 14.3) |
| Quinolone-susceptible | 189/282 (67.0) | 209/260 (80.4) | −13.4 (−20.7 to −6.1) |
| TMP-SMX–resistant | 106/154 (68.8) | 111/161 (68.9) | −0.1 (−10.3 to 10.1) |
| TMP-SMX–susceptible | 192/285 (67.4) | 212/275 (77.1) | −9.7 (−17.1 to −2.4) |
| ESBL-positive, quinolone-resistant, TMP-SMX–resistant | 43/59 (72.9) | 47/75 (62.7) | 10.2 (−5.5 to 26.0) |
ESBL testing was not performed on 5 sulopenem patients and 4 ertapenem patients.
Abbreviations: ESBL, extended-spectrum beta-lactamase; TMP-SMX, trimethoprim-sulfamethoxazole.