Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-30 @ 1:54 AM
Study NCT ID:
NCT00518661
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2007-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Quinolone Resistance Among ESBL Producing Klebsiella Species
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007710', 'term': 'Klebsiella Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2007-08-17', 'studyFirstSubmitQcDate': '2007-08-17', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['quinolone resistance', 'ESBL', 'Klebsiella species', 'Infection'], 'conditions': ['Quinolone Resistance', 'ESBL', 'Klebsiella Species', 'Infection']}, 'descriptionModule': {'briefSummary': 'This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed.', 'detailedDescription': 'This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed. This research is (c) important because identification of risk factors may allow earlier initiation of appropriate therapy in patients infected with these bacteria. Additionally, we will identify whether horizontal spread is responsible for this increasing trend.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'quinolone resistant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be quinolone resistant among ESBL producing klebsiella species\n\nExclusion Criteria:\n\n* Those not meeting entry criteria'}, 'identificationModule': {'nctId': 'NCT00518661', 'briefTitle': 'Risk Factors for Quinolone Resistance Among ESBL Producing Klebsiella Species', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Risk Factors for Quinolone Resistance Among Extended-Spectrum Beta-Lactamase-Producing Klebsiella Species', 'orgStudyIdInfo': {'id': 'PRO07070356'}, 'secondaryIdInfos': [{'id': 'investigator funding', 'type': 'OTHER', 'domain': 'UPMC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Brian Potoski, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yohei Doi', 'investigatorAffiliation': 'University of Pittsburgh'}}}}