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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669994
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Drug: Ciprofloxacin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Drug: Ciprofloxacin
Cipro XR 500 mg tablets taken once daily

Primary Outcome Measures :
  1. Bacteriologic outcome in patients with UTI caused by S. saprophyticus [ Time Frame: 4-11 days post-treatment ]

Secondary Outcome Measures :
  1. Adverse Events Collection [ Time Frame: Up to 4-11 days post-treatment ]
  2. Clinical Response [ Time Frame: 4-11 days post-treatment ]
  3. Incidence of premature terminations [ Time Frame: Premature discontinuation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00669994

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00669994     History of Changes
Other Study ID Numbers: 100546
First Posted: May 1, 2008    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Urinary Tract Infection

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors