Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-14 @ 12:47 AM
Study NCT ID:
NCT01961206
Status:
COMPLETED
Last Update Posted:
2015-11-23
First Post:
2013-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Onset Bacteremia Due to ESBL Producing E.Coli or K.Pneumoniae in China: Prevalence, Risk Factors and Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'bacterial strains'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 960}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-19', 'studyFirstSubmitDate': '2013-09-30', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk factors for community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Community Acquired Infection']}, 'referencesModule': {'references': [{'pmid': '19995215', 'type': 'RESULT', 'citation': 'Rodriguez-Bano J, Picon E, Gijon P, Hernandez JR, Ruiz M, Pena C, Almela M, Almirante B, Grill F, Colomina J, Gimenez M, Oliver A, Horcajada JP, Navarro G, Coloma A, Pascual A; Spanish Network for Research in Infectious Diseases (REIPI). Community-onset bacteremia due to extended-spectrum beta-lactamase-producing Escherichia coli: risk factors and prognosis. Clin Infect Dis. 2010 Jan 1;50(1):40-8. doi: 10.1086/649537.'}, {'pmid': '18624669', 'type': 'RESULT', 'citation': 'Apisarnthanarak A, Kiratisin P, Mundy LM. Predictors of mortality from community-onset bloodstream infections due to extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae. Infect Control Hosp Epidemiol. 2008 Jul;29(7):671-4. doi: 10.1086/588082.'}, {'pmid': '27624571', 'type': 'DERIVED', 'citation': 'Quan J, Zhao D, Liu L, Chen Y, Zhou J, Jiang Y, Du X, Zhou Z, Akova M, Yu Y. High prevalence of ESBL-producing Escherichia coli and Klebsiella pneumoniae in community-onset bloodstream infections in China. J Antimicrob Chemother. 2017 Jan;72(1):273-280. doi: 10.1093/jac/dkw372. Epub 2016 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'Escherichia coli is the leading cause of community-onset gram-negative bloodstream infections. There has been a dramatic increase in the prevalence of extended-spectrum b-lactamases producing E. coli and K.pneumoniae in the community, which was considered to be exclusively a nosocomial pathogen in recent years. As a result, the treatment options for community-onset infections due to ESBL-producing E. coli or K.pneumoniae are limited and the initial empirical therapy is often ineffective and associated with increased mortality. Although there were some reports of the risk factors of community-onset ESBL producing E. coli in Spain, Korea, and Canada, few empirical data were available about China. Therefore, the investigators aim was to investigate the epidemiology, risk factors, and the hospital outcomes for patients with community-onset bacteremia caused by ESBL producing E. coli or K.pneumoniae in China.', 'detailedDescription': 'Eligibility criteria:\n\n1. Inclusion criteria:Blood cultures demonstrated E.coli or K.pneumoniae among nonhospitalized patients or within 48 h after hospitalization.\n2. Exclusion criteria:Patients with hospitalization in the past 1 month.\n\nOutcome measures:\n\n1. Risk factors for community-onset bacteremia due to ESBL producing E. coli or K.pneumoniae\n2. Microbial and clinical efficacy of commonly used antibiotics for community-onset bacteremia due to ESBL producing E. coli or K.pneumoniae'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients visited any of the 28 particitant hospitals during the study period were screened. Patients with community-onset bacteremia caused by E.coli or K. pneumoniae and without a recent hospitalization in any hospital will be included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years old\n* community-onset bacteremia\n\nExclusion Criteria:\n\n* recent hospitalization within one month in any hospital'}, 'identificationModule': {'nctId': 'NCT01961206', 'briefTitle': 'Community-Onset Bacteremia Due to ESBL Producing E.Coli or K.Pneumoniae in China: Prevalence, Risk Factors and Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Community-Onset Bacteremia Due to Extended-Spectrum β-Lactamase (ESBL)Producing Escherichia Coli or Klebsiella Pneumoniae in China: Prevalence, Risk Factors and Prognosis', 'orgStudyIdInfo': {'id': 'SRRSH-ESBL01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case Patients', 'description': 'Case Patients with Community-Onset Bacteremia Due toESBL producing E.coli or K.pneumoniae', 'interventionNames': ['Other: bacteremia caused by ESBL producing E.coli or K.pneumoniae']}, {'label': 'control group', 'description': 'bacteremia caused by ESBL producing E.coli or K.pneumoniae'}], 'interventions': [{'name': 'bacteremia caused by ESBL producing E.coli or K.pneumoniae', 'type': 'OTHER', 'description': 'community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae', 'armGroupLabels': ['Case Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yun-song YU, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jian-cang Zhou M.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Jian-cang Zhou M.D.', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}