Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT01392118
Status:
UNKNOWN
Last Update Posted:
2011-07-12
First Post:
2011-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'ESBL strains of E. coli or K. pneumoniae from blood cultures under normal practice'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-11', 'studyFirstSubmitDate': '2011-07-10', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the risk factor, molecular character and susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia', 'detailedDescription': '1. To characterize the genotypes of the pathogens isolated from recurrent ESBL-EK bacteremia versus non-recurrent ESBL-EK bacteremia to differentiate relapse from reinfection\n\n * recurrent versus non-recurrent\n * relapse versus reinfection\n2. To correlate the patient characteristics, clinical manifestations, severity of illness (the modified Pitt bacteremia score), diagnosis of deep-site infection, co-morbid conditions (including diabetes mellitus, hepatic and renal dysfunction), length of stay in ICU/hospitalization, the presence of invasive procedures, source of pathogen (community acquired or nosocomial infection), antimicrobial regimen (i.e carbapenems versus non-carbapenems(flomoxef or quinolones), microbiological characteristics (E coli and Kleb. pneumoniae) and outcome endpoints (clinical outcome and mortality) with ESBL recurrence and genotypes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In a tertiary care hospital, every adult patient with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010 will be recruited into this study. Patients who died within 48h after first episode of ESBL-EK bloodstream infection will be excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age\\>=18 years) with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010\n\nExclusion Criteria:\n\n* Patients who died within 48h after first episode of ESBL-EK bloodstream infection'}, 'identificationModule': {'nctId': 'NCT01392118', 'briefTitle': 'Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change', 'orgStudyIdInfo': {'id': 'MISP38634'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'country': 'Taiwan', 'contacts': [{'name': 'Chen-Hsiang Lee, M.D.', 'role': 'CONTACT', 'email': 'lee900@adm.cgmh.org.tw', 'phone': '886-7-7317123', 'phoneExt': '8304'}, {'name': 'Chen-Hsiang Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chang Gung Medical Foundation, Kaohsiung Branch', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Chen-Hsiang Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Medical Foundation, Kaohsiung Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Chen-Hsiang Lee / Chief; Division of Infectious Diseases', 'oldOrganization': 'Chang Gung Medical Foundation, Kaohsiung Branch'}}}}