Iterum Therapeutics International Limited

The purpose of this research study is to compare the effectiveness of oral sulopenem etzadroxil/probenecid tablets versus oral amoxicillin/clavulanate capsules in adult women with uncomplicated urinary tract infection (UTI). If you are diagnosed with unclomplicated UTI, you will be randomized to one of the two following study treatment groups:

A placebo is an inactive substance that looks like the actual medication but contains no active ingredients. This study is double-blind, which means neither you nor the study doctor evaluating your infection will know if you are assigned to take study drug or comparator study drug. In the event of an emergency, the study doctor can find out which study drug the you are receiving.

• Sulopenem etzadroxil/probenecid 500 mg/500 mg tablet along with a placebo capsule, twice daily for 5 days
• Oral amoxicillin/clavulanate 875 mg/125 mg capsule, along with a placebo tablet, twice daily for 5 days

Inova OB-GYN Falls Church
500 N. Washington St. #300
Falls Church, VA 22046

Inova Fairfax Medical Campus
3300 Gallows Rd.
Falls Church, VA 22042

• 18 years of age or older
• Presenting signs and symptoms of uncomplicated UTI

• Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
• You are pregnant, or are currently breastfeeding
• Current resident of a long-term care facility
• Any history of trauma to the pelvis or urinary tract
• Females of child-bearing potential who are unable to take adequate contraceptive precautions
• Poorly controlled diabetes, history of uric acid kidney stones