Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
Condition: UTI - Lower Urinary Tract Infection; Antibiotic Resistant Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Ciprofloxacin
Intervention description: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label study of ciprofloxacin for uncomplicated urinary tract infection
Masking: None (Open Label)
Enrollment: 250.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, Phase 4, open label, multi-center study of the clinical and
      microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract
      infections in adult women.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female patients ≥18 years of age with more than 24 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, gross hematuria

          3. A mid-stream urine specimen with:

               1. a dipstick analysis positive for nitrite AND

               2. a dipstick analysis positive for leukocyte esterase

          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 prior effective antibacterial drug therapy for uUTI for the presenting
             illness unless the recovered pathogen demonstrates resistance to initial antibiotic
             and clinical symptoms persist

          3. Concurrent use of non-study antibacterial drug therapy 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 results, if available at study entry, identify more than 2
             microorganisms regardless of colony count or patient has a potential fungal pathogen

         10. Patient's urine culture results, if available at study entry, identifies the causative
             uropathogen for the presenting illness to be resistant to ciprofloxacin

         11. Patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal
             dialysis or had a renal transplant

         12. Patient is known to have severe neutropenia

         13. Patient is known to be pregnant

         14. Patients with uncontrolled diabetes mellitus

         15. Patients with a known history of myasthenia gravis

         16. Patients who require concomitant administration of tizanidine

         17. Patients with a history of allergy to quinolones

         18. Patient is considered unlikely to survive the study period or has a rapidly
             progressive or terminal illness including septic shock which is associated with a high
             risk of mortality