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

Inclusion criteria

• Female patients ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI
• Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain, gross hematuria
• A mid-stream urine specimen with:

• a dipstick analysis positive for nitrite AND
• a dipstick analysis positive for leukocyte esterase
• 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 prior effective antibacterial drug therapy for uUTI for the presenting illness unless the recovered pathogen demonstrates resistance to initial antibiotic and clinical symptoms persist
• Concurrent use of non-study antibacterial drug therapy 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 results, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a potential fungal pathogen
• Patient's urine culture results, if available at study entry, identifies the causative uropathogen for the presenting illness to be resistant to ciprofloxacin
• Patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal dialysis or had a renal transplant
• Patient is known to have severe neutropenia
• Patient is known to be pregnant
• Patients with uncontrolled diabetes mellitus
• Patients with a known history of myasthenia gravis
• Patients who require concomitant administration of tizanidine
• Patients with a history of allergy to quinolones
• 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