Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT00766259
Status:
WITHDRAWN
Last Update Posted:
2024-05-03
First Post:
2008-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship of Staphylococcal Colonization to Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'only bacterial strains collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'poor accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2008-10-02', 'studyFirstSubmitQcDate': '2008-10-02', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of infection strains which were also colonizer earlier', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Duration of strain colonization among co-morbidity cohorts', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['methicillin-resistant Staphylococcus', 'colonization'], 'conditions': ['MRSA Infection']}, 'descriptionModule': {'briefSummary': "Inpatients will be prospectively have nares screened and MRSA strains collected. All clinical MRSA strains of patients will also be prospectively collected. A sensitive strain discrimination test of spa typing will be used to determine if the strains are related. Hypotheses are\n\n1. Strain colonization durations vary and may be very short in days to weeks.\n2. Colonizing strains rarely infect 3) Both 1 and 2 may be affected by the patient's co-morbidity.", 'detailedDescription': 'Patients of special interest:\n\n1. Skin and soft tissue infection\n2. Nursing home patients\n3. Vascular patients with leg lesions\n4. ICU patients\n5. Hemodialysis patients\n6. Outpatients without history of infections(controls) will have nares screened for MRSA and then monthly for 1 year.\n\nAll strains will be saved and spa typed. Analysis of the data will be performed to answer the questions and hypotheses and to answer is the screening effort and the isolation of patients for MRSA as is in current practice worthwhile and is there any scientific data to support this practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients admited', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted and one of the co-morbid groups\n* Ambulatory care patient with no infections\n\nExclusion Criteria:\n\n* All others'}, 'identificationModule': {'nctId': 'NCT00766259', 'briefTitle': 'Relationship of Staphylococcal Colonization to Infection', 'organization': {'class': 'OTHER', 'fullName': 'Veterans BioMedical Research Institute'}, 'officialTitle': 'Relationship of Staphylococcal Colonization to Infection', 'orgStudyIdInfo': {'id': 'Eng-MRSA'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Hemodialysis'}, {'label': '2', 'description': 'Intensive care'}, {'label': '3', 'description': 'vascular patients with open wounds'}, {'label': '4', 'description': 'nursing home'}, {'label': '5', 'description': 'skin infections'}, {'label': '6', 'description': 'control- ambulatory care clinic patients with no infections'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Veterans BioMedical Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}