Overview

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A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infections in adult women.

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Preparation and Dispensing:
Each patient will receive a kit containing one 5 day treatment course of either sulopenem etzadroxil/probenecid and placebo ciprofloxacin or placebo sulopenem etzadroxil/probenecid and ciprofloxacin.

Administration:
Patients will take one sulopenem etzadroxil/probenecid or placebo tablet twice daily for 5 days and they will take one over-encapsulated ciprofloxacin or placebo capsule twice daily for 3 days. The first dose of each medication will be administered under the supervision of study site personnel to help ensure compliance with dosing directions.
Patients found to have pathogens isolated from urine cultures that are resistant to quinolones or carbapenems may be allowed to continue on study drug therapy to complete the 5 day duration of treatment based on clinical response and investigator judgement, and are not required to receive alternative antibiotic therapy.