Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT00167960
Status:
COMPLETED
Last Update Posted:
2007-03-15
First Post:
2005-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010878', 'term': 'Piperacillin'}, {'id': 'D000078142', 'term': 'Tazobactam'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010397', 'term': 'Penicillanic Acid'}, {'id': 'D013450', 'term': 'Sulfones'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'lastUpdateSubmitDate': '2007-03-14', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2007-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Bacterial Infections'], 'conditions': ['Gram-Positive Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'To determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to or transferred to the SICU.\n* Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.\n* Females who are pregnant and breast feeding\n* Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.\n* Those who have already been participating other clinical study related with antibiotics.'}, 'identificationModule': {'nctId': 'NCT00167960', 'briefTitle': 'Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.', 'orgStudyIdInfo': {'id': '0910X-101525'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Piperacillin/tazobactam and other β-lactam/β-lactamase', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}