Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
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
1 other identifier
interventional
180
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2003
Shorter than P25 for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 29, 2008
CompletedFirst Posted
Study publicly available on registry
May 1, 2008
CompletedDecember 19, 2014
December 1, 2014
April 29, 2008
December 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bacteriologic outcome in patients with UTI caused by S. saprophyticus
4-11 days post-treatment
Secondary Outcomes (3)
Adverse Events Collection
Up to 4-11 days post-treatment
Clinical Response
4-11 days post-treatment
Incidence of premature terminations
Premature discontinuation
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (31)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Birmingham, Alabama, 35242, United States
Unknown Facility
Pelham, Alabama, 35124, United States
Unknown Facility
Phoenix, Arizona, 85023, United States
Unknown Facility
Laguna Hills, California, 92653, United States
Unknown Facility
Long Beach, California, 90806, United States
Unknown Facility
San Diego, California, 92182-4701, United States
Unknown Facility
San Luis Obispo, California, 93401, United States
Unknown Facility
San Mateo, California, 94403-4398, United States
Unknown Facility
Sylmar, California, 91342, United States
Unknown Facility
Yorba Linda, California, 92886, United States
Unknown Facility
Avon, Connecticut, 06001, United States
Unknown Facility
Clearwater, Florida, 33761, United States
Unknown Facility
Pembroke Pines, Florida, 33024, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Milford, Massachusetts, 01757, United States
Unknown Facility
Royal Oak, Michigan, 48073-6769, United States
Unknown Facility
Elizabeth, New Jersey, 07202-3672, United States
Unknown Facility
Holmdel, New Jersey, 07733, United States
Unknown Facility
Camillus, New York, 13031, United States
Unknown Facility
Beaver, Pennsylvania, 15009, United States
Unknown Facility
Feasterville, Pennsylvania, 19053, United States
Unknown Facility
Hatboro, Pennsylvania, 19040, United States
Unknown Facility
Summerville, South Carolina, 29485, United States
Unknown Facility
San Antonio, Texas, 78209, United States
Unknown Facility
Murray, Utah, 84107, United States
Unknown Facility
Salt Lake City, Utah, 84102, United States
Unknown Facility
Salt Lake City, Utah, 84109, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
West Jordan, Utah, 84088, United States
Unknown Facility
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2008
First Posted
May 1, 2008
Study Start
July 1, 2003
Study Completion
October 1, 2003
Last Updated
December 19, 2014
Record last verified: 2014-12