Table 5.
Primary and Secondary Efficacy End Points
| Time of End Point Assessment | Sulopenem etzadroxil/Probenecid n/N (%) |
Ciprofloxacin n/N (%) |
Absolute Difference (95% Confidence Interval) |
|---|---|---|---|
| Combined clinical and microbiologic response | |||
| Day 5 (end of treatment) | |||
| ȃmMITT-R | 95/147 (64.6) | 42/139 (30.2) | 34.4 (23.1 to 44.8) |
| ȃmMITT-S | 240/370 (64.9) | 271/415 (65.3) | −0.4 (−7.1 to 6.2) |
| ȃmMITT | 335/517 (64.8) | 313/554 (56.5) | 8.3 (2.4 to 14.1) |
| Day 12 (test of cure: primary end point) | |||
| ȃmMITT-R | 92/147 (62.6) | 50/139 (36.0) | 26.6 (15.1 to 37.4) |
| ȃmMITT-S | 247/370 (66.8) | 326/415 (78.6) | −11.8 (−18.0 to −5.6) |
| ȃmMITT | 339/517 (65.6) | 376/554 (67.9) | −2.3 (−7.9 to 3.3) |
| Day 28 (late follow-up) | |||
| ȃmMITT-R | 100/147 (68.0) | 62/139 (44.6) | 23.4 (12.0 to 34.3) |
| ȃmMITT-S | 256/370 (69.2) | 323/415 (77.8) | −8.6 (−14.8 to −2.5) |
| ȃmMITT | 356/517 (68.9) | 385/554 (69.5) | −0.6 (−6.2 to 4.9) |
| Clinical response | |||
| Day 5 | |||
| ȃmMITT-R | 99/147 (67.3) | 83/139 (59.7) | 7.6 (−3.5 to 18.7) |
| ȃmMITT-S | 256/370 (69.2) | 290/415 (69.9) | −0.7 (−7.2 to 5.7) |
| ȃmMITT | 355/517 (68.7) | 373/554 (67.3) | 1.3 (−4.3 to 6.9) |
| Day 12 | |||
| ȃmMITT-R | 122/147 (83.0) | 87/139 (62.6) | 20.4 (10.2 to 30.4) |
| ȃmMITT-S | 300/370 (81.1) | 349/415 (84.1) | −3.0 (−8.4 to 2.3) |
| ȃmMITT | 422/517 (81.6) | 436/554 (78.7) | 2.9 (−1.9 to 7.7) |
| ȃMITT | 647/785 (82.4) | 638/794 (80.4) | 2.1 (−1.8 to 5.9) |
| Day 28 | |||
| ȃmMITT-R | 122/147 (83.0) | 82/139 (59.0) | 24.0 (13.7 to 34.0) |
| ȃmMITT-S | 295/370 (79.7) | 341/415 (82.2) | −2.4 (−8.0 to 3.1) |
| ȃmMITT | 417/517 (80.7) | 423/554 (76.4) | 4.3 (−0.6 to 9.2) |
| ȃMITT | 643/785 (81.9) | 631/794 (79.5) | 2.4 (−1.5 to 6.3) |
| Combined response | |||
| Day 12 | |||
| ȃExtended-spectrum β-lactamase–positive | 41/73 (56.2) | 34/72 (47.2) | 8.9 (−7.3, 24.8) |
| ȃβ-lactam-, ciprofloxacin-, and TMP–SMX-nonsusceptible | 40/65 (61.5) | 19/51 (37.3) | 24.3 (5.9 to 41.0) |
| ȃβ-lactam-, ciprofloxacin-, TMP–SMX-, and nitrofurantoin-nonsusceptible | 20/25 (80.0) | 12/28 (42.9) | 37.1 (10.8 to 58.5) |
Abbreviations: mMITT, microbiologic modified intent-to-treat with a qualifying baseline urine isolate; mMITT-R, microbiologic modified intent-to-treat with a qualifying baseline urine isolate nonsusceptible to ciprofloxacin; mMITT-S, microbiologic modified intent-to-treat with a qualifying baseline urine isolate susceptible to ciprofloxacin; TMP–SMX, trimethoprim–sulfamethoxazole.