Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections

Inclusion Criteria

• •Non-pregnant, non-lactating female outpatients between the ages of 18 - 44 years (inclusive)
• •Patients with at least two of the following clinical signs and symptoms of an uUTI:
• •* Dysuria
• •* Frequency
• •* Urgency
• •* Suprapubic pain
• •Patients with onset of symptoms \< 72 hours prior to study entry
• •Patients with one positive pre-treatment clean-catch midstream urine culture at enrollment in the study, defined as \> 10000 CFU/mL (study drug treatment is permitted prior to the availability of urine culture results)
• •Positive leukocyte esterase (LE) (1+ or greater) utilizing a urine dipstick method of analysis
• •Patients willing to give written informed consent
• •Cultures must be performed on pre-treatment clean-catch midstream urine (MSU) specimens
• •Patients with symptoms of a UTI within the 4 weeks prior to the present episode
• •Patients with the onset of symptoms \>72 hours prior to study entry
• •Patients with three or more episodes of any UTI in the past 12 months
• •Patients with evidence of factors predisposing to the development of UTIs, including calculi, stricture, primary renal disease (e.g. polycystic renal disease), or neurogenic bladder
• •Patients who received systemic antimicrobial therapy within 48 hours prior to entry
• •Patients with a neutrophil count \< 1000/mm3, CD4 \< 200/mm3 or other conditions associated with significant depression in host defense; HIV testing is not mandatory
• •Patients requiring concomitant systemic antibacterial therapy with agents not specified in this protocol
• •Patients with a previous history of tendinopathy associated with fluoroquinolones
• •Patients diagnosed with a rapidly fatal underlying disease (death expected within six months)
• •Patients requiring concomitant use of theophylline
• •Patients previously enrolled in this clinical study
• •Patients taking an investigational drug in the last 30 days