Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-24 @ 10:02 PM
Study NCT ID:
NCT00573235
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2007-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "All samples provided to the investigators are deidentified by the honest broker and will be coded with numbers. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location that only the honest broker has access to. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time with the research investigators have access to any patient identifers."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2007-12-12', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Review whether ESBL-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated or community-associated.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['isolates', 'infection', 'E coli isolates'], 'conditions': ['Enterobacteriaceae Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes.', 'detailedDescription': 'This is chart review at UPMC. There is no human interaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.'}, 'identificationModule': {'nctId': 'NCT00573235', 'briefTitle': 'Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli', 'orgStudyIdInfo': {'id': 'PRO07090323'}}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Yohei Doi, MD', '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'}}}}