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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03445195 | Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections | PHASE2 | COMPLETED | 80 | — | — | Jan 17, 2018 | May 17, 2018 | Jan 22, 2020 | 4 | Bulgaria |
The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit.
| Arm | Type | Description |
|---|---|---|
| Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin | EXPERIMENTAL | - |
| Placebo + Imipenem/Cilastatin | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sulbactam-ETX2514 | DRUG | The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h. |
| Placebo | DRUG | Matching 1g IV solution. |
| Imipenem-cilastatin | DRUG | All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. |
Inclusion Criteria: * A signed informed consent form (ICF). If a study patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient as permitted by local law and institutional Standard Operat...