Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
NCT ID: NCT00669994
Last Updated: 2014-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
180 participants
INTERVENTIONAL
2003-07-31
2003-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Ciprofloxacin
Cipro XR 500 mg tablets taken once daily
Interventions
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Ciprofloxacin
Cipro XR 500 mg tablets taken once daily
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
44 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Pelham, Alabama, United States
Phoenix, Arizona, United States
Laguna Hills, California, United States
Long Beach, California, United States
San Diego, California, United States
San Luis Obispo, California, United States
San Mateo, California, United States
Sylmar, California, United States
Yorba Linda, California, United States
Avon, Connecticut, United States
Clearwater, Florida, United States
Pembroke Pines, Florida, United States
Evansville, Indiana, United States
Milford, Massachusetts, United States
Royal Oak, Michigan, United States
Elizabeth, New Jersey, United States
Holmdel, New Jersey, United States
Camillus, New York, United States
Beaver, Pennsylvania, United States
Feasterville, Pennsylvania, United States
Hatboro, Pennsylvania, United States
Summerville, South Carolina, United States
San Antonio, Texas, United States
Murray, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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100546
Identifier Type: -
Identifier Source: org_study_id