Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-29 @ 9:08 PM
Study NCT ID:
NCT00958295
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2009-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D003556', 'term': 'Cystitis'}], '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'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Bacterial strains isolated in urine cultures'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2009-08-12', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial epidemiology of acute uncomplicated cystitis', 'timeFrame': 'march 2010'}], 'secondaryOutcomes': [{'measure': 'Comparison of urine dipstick tests and urine culture results', 'timeFrame': 'march 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urinary tract infection', 'cystitis'], 'conditions': ['Acute Uncomplicated Bacterial Cystitis']}, 'referencesModule': {'references': [{'pmid': '24612927', 'type': 'DERIVED', 'citation': 'Etienne M, Lefebvre E, Frebourg N, Hamel H, Pestel-Caron M, Caron F; Bacyst Study Group. Antibiotic treatment of acute uncomplicated cystitis based on rapid urine test and local epidemiology: lessons from a primary care series. BMC Infect Dis. 2014 Mar 11;14:137. doi: 10.1186/1471-2334-14-137.'}]}, 'descriptionModule': {'briefSummary': 'Acute uncomplicated bacterial cystitis is common in general practice. Cystitis is at the second raw of antibiotic treatment indications. It has been now recommended not to perform any urine culture for more than 20 years; hence, the bacterial epidemiology of acute uncomplicated cystitis is surprisingly relatively unknown. The available bacteriological data mainly describe the epidemiology of complicated urinary tract infections or upper urinary tract infections, but the causative bacteria and the resistance rates might differ from those of uncomplicated cystitis. As an example, it is unknown to what extent Staphylococcus saprophyticus is the causative agent of uncomplicated cystitis.\n\nMoreover, the urine dipstick test have been evaluated in laboratories. But their interpretation in current practice might not be so easy: in particular, the nitrite detection depends on the bacterial concentration. The nitrite detection, produced in enterobacteriaceae related infections might have therapeutical consequences: trométamol-fosfomycine is almost constantly active on enterobacteriaceae, but ineffective on staphylococci. Knowing the increasing prevalence of fluoroquinolone-resistant enterobacteriaceae, the use of fosfomycin in nitrite positive uncomplicated cystitis might preserve the susceptibility of fluoroquinolones during pyelonephritis.\n\nThis study will describe:\n\n* the bacterial epidemiology of acute uncomplicated cystitis in general practice,\n* the correlation in between urine dipstick and urine culture in general practice,\n* the prediction of enterobacterial infection by the nitrite detection, AND\n* the antibiotics prescribed by the practitioners for uncomplicated acute cystitis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult female, no comorbidities.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* \\>18 years old\n* urinary symptoms\n\nExclusion Criteria:\n\n* fever\n* lumbar pain\n* co-morbidities'}, 'identificationModule': {'nctId': 'NCT00958295', 'acronym': 'BaCyst', 'briefTitle': 'Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice: Description and Prediction by Urine Dipstick Test', 'orgStudyIdInfo': {'id': '2008/119/HP'}}, 'contactsLocationsModule': {'locations': [{'zip': '27400', 'city': 'Louviers', 'country': 'France', 'facility': 'JULIENNE Pascal', 'geoPoint': {'lat': 49.21667, 'lon': 1.16667}}], 'overallOfficials': [{'name': 'Manuel ETIENNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Infectious diseases department, rouen university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}