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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00669994

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 IV

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:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

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:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00669994 History of Changes
Other Study ID Numbers:	100546
Study First Received:	April 29, 2008
Last Updated:	June 16, 2009
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 February 09, 2012