Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 4:10 PM
Study NCT ID:
NCT00669994
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2008-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-18', 'studyFirstSubmitDate': '2008-04-29', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacteriologic outcome in patients with UTI caused by S. saprophyticus', 'timeFrame': '4-11 days post-treatment'}], 'secondaryOutcomes': [{'measure': 'Adverse Events Collection', 'timeFrame': 'Up to 4-11 days post-treatment'}, {'measure': 'Clinical Response', 'timeFrame': '4-11 days post-treatment'}, {'measure': 'Incidence of premature terminations', 'timeFrame': 'Premature discontinuation'}]}, 'conditionsModule': {'keywords': ['UTI', 'Urinary Tract Infection'], 'conditions': ['Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant, non-lactating female outpatients between the ages of 18 - 44 years (inclusive)\n* Patients with at least two of the following clinical signs and symptoms of an uUTI:\n\n * Dysuria\n * Frequency\n * Urgency\n * Suprapubic pain\n* Patients with onset of symptoms \\< 72 hours prior to study entry\n* 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)\n* Positive leukocyte esterase (LE) (1+ or greater) utilizing a urine dipstick method of analysis\n* Patients willing to give written informed consent\n* Cultures must be performed on pre-treatment clean-catch midstream urine (MSU) specimens\n\nExclusion Criteria:\n\n* Males\n* Women who are pregnant, nursing, or not using two medically accepted, effective methods of birth control\n* Patients with known or suspected hypersensitivity to quinolones\n* Patients unable to take oral medication for any reason\n* Patients with an asymptomatic bacteriuria\n* 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\n* 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\n* Patients with symptoms of a UTI within the 4 weeks prior to the present episode\n* Patients with the onset of symptoms \\>72 hours prior to study entry\n* Patients with three or more episodes of any UTI in the past 12 months\n* 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\n* Patients who received systemic antimicrobial therapy within 48 hours prior to entry\n* 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\n* Patients requiring concomitant systemic antibacterial therapy with agents not specified in this protocol\n* Patients with a previous history of tendinopathy associated with fluoroquinolones\n* Patients diagnosed with a rapidly fatal underlying disease (death expected within six months)\n* Patients requiring concomitant use of theophylline\n* Patients previously enrolled in this clinical study\n* Patients taking an investigational drug in the last 30 days'}, 'identificationModule': {'nctId': 'NCT00669994', 'briefTitle': 'Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '100546'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Ciprofloxacin']}], 'interventions': [{'name': 'Ciprofloxacin', 'type': 'DRUG', 'description': 'Cipro XR 500 mg tablets taken once daily', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35124', 'city': 'Pelham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.28567, 'lon': -86.80999}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92182-4701', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93401', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '94403-4398', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '92886', 'city': 'Yorba Linda', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.88863, 'lon': -117.81311}}, {'zip': '06001', 'city': 'Avon', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.80982, 'lon': -72.83065}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '01757', 'city': 'Milford', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.13982, 'lon': -71.51617}}, {'zip': '48073-6769', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '07202-3672', 'city': 'Elizabeth', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.66399, 'lon': -74.2107}}, {'zip': '07733', 'city': 'Holmdel', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.34511, 'lon': -74.18403}}, {'zip': '13031', 'city': 'Camillus', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.03923, 'lon': -76.3041}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '19053', 'city': 'Feasterville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.15, 'lon': -74.997}}, {'zip': '19040', 'city': 'Hatboro', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.17428, 'lon': -75.10684}}, {'zip': '29485', 'city': 'Summerville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.0185, 'lon': -80.17565}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84102', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}