Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 5:02 PM
Study NCT ID:
NCT03966534
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2019-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Test Order and Culture Contamination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective partially blinded randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 970}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood culture contamination', 'timeFrame': 'up to 7 days from obtaining blood culture', 'description': 'Growth of bacteria defined as blood culture contaminants (for example coagulase negative staphylococci in one bottle only).'}], 'secondaryOutcomes': [{'measure': 'Patient length of stay', 'timeFrame': 'up to 3 months from arrival', 'description': 'Length of stay from arrival at Emergency room until discharge in hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Culture Contamination']}, 'referencesModule': {'references': [{'pmid': '31570942', 'type': 'DERIVED', 'citation': 'Zimmerman FS, Karameh H, Ben-Chetrit E, Zalut T, Assous M, Levin PD. Modification of Blood Test Draw Order to Reduce Blood Culture Contamination: A Randomized Clinical Trial. Clin Infect Dis. 2020 Aug 22;71(5):1215-1220. doi: 10.1093/cid/ciz971.'}]}, 'descriptionModule': {'briefSummary': 'A randomized partially controlled study to examine the effect of blood diversion into a heparin lithium tube on the incidence of blood culture contamination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Presence in Emergency Room during extended office hours (0800-2000 on weekdays(\n* Clinical requirement for Blood culture and biochemistry tests from venepuncture\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03966534', 'briefTitle': 'Blood Test Order and Culture Contamination', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'A Randomized Controlled Study of Blood Test Draw Order to Reduce Blood Culture Contamination', 'orgStudyIdInfo': {'id': '0177-18-SZMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Blood culture obtained as first test after venipuncture and prior to biochemistry test'}, {'type': 'EXPERIMENTAL', 'label': 'Diversion Group', 'description': 'Biochemistry test obtained as first test after venepuncture and prior to blood culture', 'interventionNames': ['Other: Blood diversion']}], 'interventions': [{'name': 'Blood diversion', 'type': 'OTHER', 'description': 'Diversion of initial blood obtained at venipuncture to biochemistry tube in order to try and reduce incidence of blood culture contamination', 'armGroupLabels': ['Diversion Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}