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

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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Locations
Status
LocationsStatus
Locations

Investigative Site

Clearwater, United States, 33761

Status
Completed
 
Locations

Investigative Site

Beaver, United States, 15009

Status
Completed
 
Locations

Investigative Site

Sylmar, United States, 91342

Status
Completed
 
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Investigative Site

Murray, United States, 84107

Status
Completed
 
Locations

Investigative Site

San Antonio, United States, 78209

Status
Completed
 
Locations

Investigative Site

Elizabeth, United States, 07202-3672

Status
Completed
 
Locations

Investigative Site

Holmdel, United States, 07733

Status
Completed
 
Locations

Investigative Site

Laguna Woods, United States, 92637

Status
Completed
 
Locations

Investigative Site

West Jordan, United States, 84088

Status
Completed
 
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Investigative Site

Phoenix, United States, 85023

Status
Completed
 
Locations

Investigative Site

Birmingham, United States, 35242

Status
Completed
 
Locations

Investigative Site

Yorba Linda, United States, 92886

Status
Completed
 
Locations

Investigative Site

Royal Oak, United States, 48073

Status
Completed
 
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Investigative Site

Avon, United States, 06001

Status
Completed
 
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Investigative Site

Camillus, United States, 13031

Status
Completed
 
Locations

Investigative Site

Salt Lake City, United States, 84121

Status
Completed
 
Locations

Investigative Site

Salt Lake City, United States, 84109

Status
Completed
 
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Investigative Site

Milford, United States, 01757

Status
Completed
 
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Investigative Site

San Diego, United States, 92182-4701

Status
Completed
 
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Investigative Site

Pelham, United States, 35124

Status
Completed
 
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Investigative Site

San Luis Obispo, United States, 93401

Status
Completed
 
Locations

Investigative Site

Salt Lake City, United States, 84102

Status
Completed
 
Locations

Investigative Site

Pembroke Pines, United States, 33024

Status
Completed
 
Locations

Investigative Site

Summerville, United States, 29485

Status
Completed
 
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Investigative Site

Feasterville Trevose, United States, 19053

Status
Completed
 
Locations

Investigative Site

Evansville, United States, 47714

Status
Completed
 
Locations

Investigative Site

Hatboro, United States, 19040

Status
Completed
 
Locations

Investigative Site

Birmingham, United States, 35205

Status
Completed
 

Trial Design