Table 4.
Overall Response at Test of Cure by Step-Down Category: Microbiologic Modified Intent-to-Treat Population
| Outcome | Sulopenem, n/N (%) |
Ertapenem, n/N (%) |
Difference, % (95% Confidence Interval) |
|---|---|---|---|
| All patients | |||
| ȃPrimary end point: overall success (test of cure) | 301/444 (67.8) | 325/440 (73.9) | −6.1 (−12.0 to −.1) |
| ȃReason for failure: asymptomatic bacteriuria | 93 (20.9) | 59 (13.4) | |
| Patients with ciprofloxacin-susceptible isolates by treatment regimen | |||
| Sulopenem IV/oral sulopenem, n/N (%) | Ertapenem IV/oral ciprofloxacin, n/N (%) | ||
| ȃOverall success | 168/248 (67.7) | 186/215 (86.5) | −18.8 (−26.1 to −11.0) |
| ȃReason for failure: asymptomatic bacteriuria | 54 (21.8) | 10 (4.7) | |
| Sulopenem IV only | Ertapenem IV only or ertapenem IV/oral A/C, | ||
| ȃOverall success | 19/34 (55.9) | 17/32 (53.1) | 2.8 (−20.9 to 26.2) |
| ȃReason for failure: asymptomatic bacteriuria | 7 (20.6) | 7 (21.9) | |
| Patients with ciprofloxacin-nonsusceptible isolates by treatment regimen | |||
| Sulopenem IV only or sulopenem IV/oral sulopenem | Ertapenem IV or ertapenem IV/oral A/Ca | ||
| ȃOverall success | 114/162 (70.4) | 122/193 (63.2) | 7.2 (−2.7 to 16.8) |
| ȃReason for failure: asymptomatic bacteriuria | 32 (19.8) | 42 (21.8) | |
Abbreviations: A/C, amoxicillin-clavulanate; IV, intravenous.
Includes 5 patients for whom ciprofloxacin susceptibility testing was not performed.