Trial Condition(s):

Urinary Tract Infection

Trial to evaluate the efficacy and safety of Cipro® XR in treating female patients with lower urinary tract infections

Bayer Identifier:

100546

ClinicalTrials.gov Identifier:

NCT00669994

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
180
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Investigative Site

Clearwater, United States, 33761

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Beaver, United States, 15009

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Sylmar, United States, 91342

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Murray, United States, 84107

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San Antonio, United States, 78209

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Elizabeth, United States, 07202-3672

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Holmdel, United States, 07733

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Laguna Woods, United States, 92637

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West Jordan, United States, 84088

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Phoenix, United States, 85023

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Birmingham, United States, 35242

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Yorba Linda, United States, 92886

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Royal Oak, United States, 48073

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Avon, United States, 06001

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Camillus, United States, 13031

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Salt Lake City, United States, 84121

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Salt Lake City, United States, 84109

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Milford, United States, 01757

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San Diego, United States, 92182-4701

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Pelham, United States, 35124

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San Luis Obispo, United States, 93401

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Salt Lake City, United States, 84102

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Pembroke Pines, United States, 33024

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Summerville, United States, 29485

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Feasterville Trevose, United States, 19053

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Evansville, United States, 47714

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Hatboro, United States, 19040

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Birmingham, United States, 35205

Trial Design