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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00669994
First received: April 29, 2008
Last updated: October 10, 2013
Last verified: October 2013
  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.


Condition Intervention Phase
Urinary Tract Infection
Drug: Ciprofloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Bacteriologic outcome in patients with UTI caused by S. saprophyticus [ Time Frame: 4-11 days post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events Collection [ Time Frame: Up to 4-11 days post-treatment ] [ Designated as safety issue: Yes ]
  • Clinical Response [ Time Frame: 4-11 days post-treatment ] [ Designated as safety issue: Yes ]
  • Incidence of premature terminations [ Time Frame: Premature discontinuation ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: July 2003
Study Completion Date: October 2003
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ciprofloxacin
Cipro XR 500 mg tablets taken once daily

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669994

  Show 31 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00669994     History of Changes
Other Study ID Numbers: 100546
Study First Received: April 29, 2008
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
UTI
Urinary Tract Infection

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014