Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03357614 | Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults | PHASE3 | COMPLETED | 1,395 | — | — | Sep 18, 2018 | Dec 14, 2019 | Dec 29, 2020 | 32 | United States, Estonia +3 |
Clinical success is defined as complete resolution of cUTI symptoms present at study entry and no new cUTI symptoms; microbiologic success is defined as eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL)
| Arm | Type | Description |
|---|---|---|
| Sulopenem | EXPERIMENTAL | Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment |
| Ertapenem | ACTIVE_COMPARATOR | Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment |
| Name | Type | Description |
|---|---|---|
| Sulopenem | DRUG | Antibiotic therapy for complicated UTI |
| Sulopenem-Etzadroxil/Probenecid | DRUG | Antibiotic therapy for complicated UTI |
| Ertapenem | DRUG | Antibiotic therapy for complicated UTI |
| Ciprofloxacin | DRUG | Antibiotic therapy for complicated UTI |
| Amoxicillin-clavulanate | DRUG | Antibiotic therapy for complicated UTI |
Inclusion Criteria: 1. Adults ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI 2. Able to provide informed consent 3. Clinically documented pyelonephritis or complicated urinary tract infection: 1. Pyelonephritis with normal anatomy 2. Complicated UTI as def...