At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
Sulbactam-ETX2514 +2 moredrug
Likely dose
Sulbactam-ETX2514 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
In Brief
A Phase 2 clinical trial evaluating Sulbactam-ETX2514, Placebo, and 1 other intervention for Complicated Urinary Tract Infection and Acute Pyelonephritis. Completed, enrolled 80 participants across 4 sites.
Detailed Summary
This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedFeb 2018
Primary CompletionMay 2018
TodayJul 2026
First PostedFeb 26, 2018
Enrollment StartJan 17, 2018
Primary CompletionMay 17, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.3 years ago
Interventions
Sulbactam-ETX2514drug
The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Placebodrug
Matching 1g IV solution.
Imipenem-cilastatindrug
All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.