Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-05 @ 6:02 PM
Study NCT ID:
NCT00541632
Status:
TERMINATED
Last Update Posted:
2024-12-02
First Post:
2007-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BacLite Rapid MRSA Clinical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}}, 'statusModule': {'whyStopped': 'performance variability', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2007-10-06', 'studyFirstSubmitQcDate': '2007-10-06', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Methicillin Resistance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects 18 years or older\n* Subjects willing to document demographic characteristics\n* Subjects willing to have their nose swabbed\n* Subjects (or legal representative) willing to sign consent and authorization forms\n\nExclusion Criteria:\n\n* Subjects who use Vicks Sinex Nasal spray or other nasal sprays\n* Subjects with prescribed nasal medical devices where collecting samples may resent more than minimal risk to subjects\n* Subjects having nasal prosthetics, jewelry or trauma to the nose or anything that may prevents sampling the anterior nares\n* Investigator believes that subject is unsuitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT00541632', 'briefTitle': 'BacLite Rapid MRSA Clinical Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'BacLite Rapid MRSA Clinical Performance', 'orgStudyIdInfo': {'id': '010737'}}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30030', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Institute for Medical Research, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern Healthcare', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '21201-1595', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27157-1042', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Werner E Bischoff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}