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.
This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Matching 1g IV solution.
All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
Universeity Multiprofile Hospital for Active Teatment
Sofia, Bulgaria
University Multiprofile Hospital for Active Teatment-Clinic of Nephrology
Sofia, Bulgaria
Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov
Sofia, Bulgaria
Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie
Sofia, Bulgaria
Number of Participants With Overall Success
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.
Time frame: From baseline through day 21
Clinical Cure
Proportion of patients with a response of clinical cure for the MITT(modified intent to treat), m-MITT (microbiologically modified intent to treat), CE(clinically evaluable), and ME(microbiologically evaluable) populations at the TOC(test of cure) visit.
Time frame: Baseline to day 21
Microbiologic Eradication
Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit
Time frame: Baseline to day 21
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