Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
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.
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