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San Luis Obispo, California 93401


Purpose:

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.


Criteria:

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


NCT ID:

NCT00669994


Primary Contact:

Study Director
Bayer Study Director
Bayer


Backup Contact:

N/A


Location Contact:

San Luis Obispo, California 93401
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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