Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

Inclusion Criteria

• Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
• Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain
• A mid-stream urine specimen with:
• a dipstick analysis positive for nitrite AND
• evidence of pyuria as defined by either:

i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine

• Has given written informed consent to participate in the study.

Exclusion Criteria

• Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
• Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
• Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI
• Patients with ileal loops or urinary stoma
• Patients with an indwelling urinary catheter in the previous 30 days
• Patients with paraplegia
• Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
• Any history of trauma to the pelvis or urinary tract
• Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
• Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
• Known history of creatinine clearance <50 mL/min
• Patients known to have liver disease
• Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions
• Patients with uncontrolled diabetes mellitus
• Patients with history of blood dyscrasias
• Patients with history of uric acid kidney stones
• Patients with acute gouty attack
• Patients on chronic methotrexate therapy
• Patient known to be immunocompromised
• Patients with a known history of myasthenia gravis
• Patients who require concomitant administration of tizanidine or valproic acid
• Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams, quinolones or probenecid
• Patient is considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
• History of seizures
• Use of any other investigational drug in the 30 days prior to the study