Expired Study
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Pelham, Alabama 35124


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.


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


Study is Available At:


Original ID:

100546


NCT ID:

NCT00669994


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

44 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bayer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

180


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bayer Study Director
Study Director
Bayer

Study Dates

Start Date:July 2003
Completion Date:October 2003
Completion Type:Actual
Verification Date:December 2014
Last Changed Date:December 18, 2014
First Received Date:April 29, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of premature terminations
Time Frame:Premature discontinuation
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Clinical Response
Time Frame:4-11 days post-treatment
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Adverse Events Collection
Time Frame:Up to 4-11 days post-treatment
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Bacteriologic outcome in patients with UTI caused by S. saprophyticus
Time Frame:4-11 days post-treatment
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ciprofloxacin
Description:Cipro XR 500 mg tablets taken once daily
Arm Name:Arm 1

Study Arms

Study Arm Type:Experimental
Arm Name:Arm 1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bayer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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