Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
This trial evaluated how effective and safe Cipro XR was in treating female patients with
 signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients
 were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was
 eliminated.
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

 Exclusion Criteria:

 -  Males

 -  Women who are pregnant, nursing, or not using two medically accepted, effective
 methods of birth control

 -  Patients with known or suspected hypersensitivity to quinolones

 -  Patients unable to take oral medication for any reason

 -  Patients with an asymptomatic bacteriuria

 -  Patients with complicated UTI, defined as: a clinical syndrome characterized by the
 development of systemic and local signs and symptoms of fever (> 38.3°C/101°F orally),
 chills, malaise, flank pain, back pain, or costovertebral angle (CVA) pain or
 tenderness

 -  Symptoms as outlined in the inclusion criteria occurring in the presence of a
 functional or anatomical abnormality of the urinary tract or in the presence of
 urinary catheterization

 -  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