Urinary Tract Infection Study
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 (uUTI) in adult women.
- 1. Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI.
- 2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
- 3. A mid-stream urine specimen with: a. a machine-read dipstick positive for nitrite.
AND, from the same urine specimen b. evidence of pyuria as defined by either:
i. a machine-read dipstick positive for leukocyte esterase OR
ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR
iii. White blood cell count ≥10 cells/HPF in the sediment of a spun urine
- 1. Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature > 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting.
- 2. Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days.