Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Ciprofloxacin
  • Cipro XR 500 mg tablets taken once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a

Primary Measures

• Bacteriologic outcome in patients with UTI caused by S. saphrophyticus
  • Time Frame: 4-11 days post-treatment
    Safety Issue?: No

Secondary Measures

• Adverse Events
  • Time Frame: up to 4-11 days post-treatment
    Safety Issue?: Yes
• Clinical Response
  • Time Frame: 4-11 days post-treatment
    Safety Issue?: Yes
• Incidence of premature terminations
  • Time Frame: premature discontinuation
    Safety Issue?: Yes

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, Section 4.2.1, 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 44 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669994

Study ID Number: 100546

ClinicalTrials.gov Identifier: NCT00669994

Health Authority: United States: Food and Drug Administration

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