Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
Condition: Uncomplicated Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Sulopenem-Etzadroxil/Probenecid; Ciprofloxacin
Intervention description: Treatment of uncomplicated urinary tract infection; Treatment of uncomplicated urinary tract infection
Intervention MeSH terms: Ciprofloxacin; Probenecid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1671.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is 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 infection (uUTI) in adult women
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to
             a urinary tract infection (UTI)

          2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency,
             pain or burning micturition, suprapubic pain

          3. A mid-stream urine specimen with:

               1. a dipstick analysis positive for nitrite AND

               2. 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

          4. Has given written informed consent to participate in the study.

        Exclusion Criteria:

          1. Presence of signs and symptoms suggestive of acute pyelonephritis: 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

          3. Concurrent use of non-study treatments that would have a potential effect on outcome
             evaluations in patients with uUTI

          4. Patients with ileal loops or urinary stoma

          5. Patients with an indwelling urinary catheter in the previous 30 days

          6. Patients with paraplegia

          7. Patients who are likely to receive ongoing antibacterial drug prophylaxis after
             treatment of uUTI (e.g., patients with vesico-ureteral reflux)

          8. Any history of trauma to the pelvis or urinary tract

          9. 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

         10. Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant

         11. Known history of creatinine clearance <50 mL/min

         12. Patients known to have liver disease

         13. Patients who are pregnant, or females of child-bearing age unable to take adequate
             contraceptive precautions

         14. Patients with uncontrolled diabetes mellitus

         15. Patients with history of blood dyscrasias

         16. Patients with history of uric acid kidney stones

         17. Patients with acute gouty attack

         18. Patients on chronic methotrexate therapy

         19. Patient known to be immunocompromised

         20. Patients with a known history of myasthenia gravis

         21. Patients who require concomitant administration of tizanidine or valproic acid

         22. Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams,
             quinolones or probenecid

         23. 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

         24. History of seizures

         25. Use of any other investigational drug in the 30 days prior to the study