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Sulbactam-ETX2514 · 1 trial · 2 indications
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...
Sulbactam-ETX2514 is an investigational small molecule being developed for the treatment of complicated urinary tract infections, including acute pyelonephritis. It is designed for hospitalized adults and is currently in Phase 2 clinical development.
Sulbactam-ETX2514 is being developed by Innoviva, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INVA. The drug is in Phase 2 clinical development for complicated urinary tract infections.
Sulbactam-ETX2514 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial for the treatment of complicated urinary tract infections has been completed.
Sulbactam-ETX2514 has been studied in a completed Phase 2 clinical trial with the identifier NCT03445195. This trial evaluated the safety and efficacy of intravenous Sulbactam-ETX2514 in hospitalized adults with complicated urinary tract infections, including acute pyelonephritis, and enrolled 80 participants.
Sulbactam-ETX2514 is a combination drug that includes the active ingredient ETX2514. The drug name reflects the combination of sulbactam and ETX2514, and it is being developed for the treatment of complicated urinary tract infections.