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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Open Label Non-comparative, Multi-center Trial to Evaluate the Efficacy and Safety of Cipro® XR 500 mg Once Daily for 3 Days in Treating Female Patients With Acute, Uncomplicated, Symptomatic Lower Urinary Tract Infections

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: Ciprofloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ciprofloxacin<br>* Cipro XR 500 mg tablets taken once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriologic outcome in patients with UTI caused by S. saprophyticus |  | 4-11 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events Collection |  | Up to 4-11 days post-treatment | 
| Clinical Response |  | 4-11 days post-treatment | 
| Incidence of premature terminations |  | Premature discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UTI, Urinary Tract Infection