Table 3.
Primary and Additional Key Efficacy End Points
| Outcome | Sulopenem (N = 444), n (%) |
Ertapenem (N = 440), n (%) |
Difference, % (95% Confidence Interval) |
|---|---|---|---|
| Microbiologic modified intent-to-treat population | |||
| Overall response at TOC (primary end point) | |||
| ȃOverall responder | 301 (67.8) | 325 (73.9) | −6.1 (−12.0 to −.1) |
| ȃOverall nonresponder | 126 (28.4) | 93 (21.1) | |
| ȃIndeterminate | 17 (3.8) | 22 (5.0) | |
| Clinical response at TOC | |||
| ȃSuccess | 397 (89.4) | 389 (88.4) | 1.0 (−3.1 to 5.1) |
| ȃFailure | 33 (7.4) | 34 (7.7) | |
| ȃIndeterminate | 14 (3.2) | 17 (3.9) | |
| Microbiologic response per patient at TOC | |||
| ȃSuccess | 316 (71.2) | 343 (78.0) | −6.8 (−12.5 to −1.1) |
| ȃFailure | 111 (25.0) | 74 (16.8) | |
| ȃIndeterminate | 17 (3.8) | 23 (5.2) | |
| Overall success at TOC by baseline infection type | |||
| ȃPyelonephritis | 179/261 (68.6) | 186/257 (72.4) | −3.8 (−11.6 to 4.1) |
| ȃComplicated urinary tract infection | 122/183 (66.7) | 139/183 (76.0) | −9.3 (−18.5 to −.1) |
| Overall success at day 5 | |||
| ȃȃCure | 198 (44.6) | 193 (43.9) | 0.7 (−5.8 to 7.3) |
| ȃȃCure + Improveda | 360 (81.1) | 352 (80.0) | 1.1 (−4.2 to 6.3) |
| ȃClinical success | |||
| ȃȃCure | 203 (45.7) | 196 (44.5) | 1.2 (−5.4 to 7.7) |
| ȃȃCure + Improveda | 369 (83.1) | 362 (82.3) | 0.8 (−4.2 to 5.9) |
| ȃMicrobiologic success | 427 (96.2) | 419 (95.2) | 0.9 (−1.7 to 3.6) |
| Overall success at end of treatment (day 10) | 385 (86.7) | 391 (88.9) | −2.2 (−6.5 to 2.2) |
| ȃClinical success | 399 (89.9) | 399 (90.7) | −0.8 (−4.7 to 3.1) |
| ȃMicrobiologic success | 418 (94.1) | 421 (95.7) | −1.5 (−4.4 to 1.4) |
| Clinical success at final visit (day 28) | 386 (86.9) | 383 (87.0) | −0.1 (−4.5 to 4.3) |
| Clinical response at TOC (intention-to-treat population) | 615/697 (88.2) | 603/698 (86.4) | 1.8 (−1.6 to 5.3) |
| Clinical response at TOC ( modified intent-to-treat population) | 615/695 (88.5) | 603/697 (86.5) | 2.0 (−1.5 to 5.4) |
Abbreviation: TOC, test of cure.
The Improved category includes patients whose clinical signs and symptoms, while not resolved, had decreased in severity from baseline.