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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03358576 | Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI) | PHASE3 | COMPLETED | 674 | — | — | Sep 18, 2018 | Oct 2, 2019 | Dec 1, 2020 | 42 | United States, Bulgaria +5 |
Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions
| Arm | Type | Description |
|---|---|---|
| Sulopenem | EXPERIMENTAL | Sulopenem 1000 mg IV once daily for at least 5 days, followed by Sulopenem-Etzadroxil/Probenecid 500 mg PO twice daily to complete 7-10 days of treatment |
| Ertapenem | ACTIVE_COMPARATOR | Ertapenem 1000 mg IV once daily for at least 5 days, followed by ciprofloxacin 500 mg PO twice daily along with metronidazole 500 mg PO four times daily. If patient is found to have causative pathogens that are resistant to ciprofloxacin they will receive amoxicillin-clavulanate 875 mg PO twice daily instead |
| Name | Type | Description |
|---|---|---|
| Ertapenem | DRUG | Antibiotic for complicated intra-abdominal infection |
| Sulopenem-Etzadroxil/Probenecid | DRUG | Antibiotic for complicated intra-abdominal infection |
| Ciprofloxacin | DRUG | Antibiotic for complicated intra-abdominal infection |
| Metronidazole | DRUG | Antibiotic for complicated intra-abdominal infection |
| Amoxicillin-Clavulanate | DRUG | Antibiotic for complicated intra-abdominal infection |
| Sulopenem | DRUG | Antibiotic for complicated intra-abdominal infection |
Inclusion Criteria: 1. Patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures. 2. Adult patients ≥18 years of age 3. EITHER: a. Intra-operative/post-operative enrollment with visual confirmation (presen...