Clinical Drug Experience Knowledgebase

Criteria

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