Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,229
Oral sulopenem twice daily for 5 days
Oral Augmentin twice daily for 5 days
Overall Success
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Time frame: Day 12+/-1 day
Overall Success Susceptible Population
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Time frame: Day 12+/-1 day
Clinical Success Modified Intent-to-treat Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time frame: Day 12+/-1 day
Clinical Success
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time frame: Day 12+/-1 day
Clinical Success Susceptible Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time frame: Day 12+/-1 day
Microbiologic Success
Eradication of the Baseline Pathogen
Time frame: Day 12+/-1 day
Microbiologic Success Susceptible Population
Microbiologic Success: Eradication of the Baseline Pathogen
Time frame: Day 12+/-1 day
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