Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-16 @ 6:50 AM
Study NCT ID:
NCT02363166
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2015-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Genomic DNA (gDNA) will be isolated from pelleted bacteria using the Roche High Pure PCR kit following the standard protocol for isolation of nucleic acids from bacteria. The quality of the extracted gDNA will be determined through gel electrophoresis and the quantity through Nanodrop2000.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 575}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Strain Relatedness Identification Through Phylogenetic Analysis', 'timeFrame': '1 Hour', 'description': 'Molecular (spa-typing) and genomic (WGS) relatedness of MRSA strains in isolates in ED populations presenting with SSTIs.'}], 'secondaryOutcomes': [{'measure': 'Strain Transmission Through Analysis of Genetic Clustering', 'timeFrame': '1 year', 'description': 'Phlyodynamic analysis of MRSA transmission course by strain'}, {'measure': 'Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation', 'timeFrame': '6 Months', 'description': 'To determine patient-level characteristics, including social and medical history, associated with a presentation related to SSTIs.'}, {'measure': 'Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI)', 'timeFrame': '6 Months', 'description': 'Compare patient-level characteristics and phylogenetic clustering between pediatric and adult patients presenting with SSTIs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Methicillin-Resistant Staphylococcus Aureus']}, 'referencesModule': {'references': [{'pmid': '19224749', 'type': 'BACKGROUND', 'citation': 'Burton DC, Edwards JR, Horan TC, Jernigan JA, Fridkin SK. Methicillin-resistant Staphylococcus aureus central line-associated bloodstream infections in US intensive care units, 1997-2007. JAMA. 2009 Feb 18;301(7):727-36. doi: 10.1001/jama.2009.153.'}, {'pmid': '19224756', 'type': 'BACKGROUND', 'citation': 'Climo MW. Decreasing MRSA infections: an end met by unclear means. JAMA. 2009 Feb 18;301(7):772-3. doi: 10.1001/jama.2009.149. No abstract available.'}, {'pmid': '23712667', 'type': 'BACKGROUND', 'citation': 'Prosperi M, Veras N, Azarian T, Rathore M, Nolan D, Rand K, Cook RL, Johnson J, Morris JG Jr, Salemi M. Molecular epidemiology of community-associated methicillin-resistant Staphylococcus aureus in the genomic era: a cross-sectional study. Sci Rep. 2013;3:1902. doi: 10.1038/srep01902.'}, {'pmid': '19128184', 'type': 'BACKGROUND', 'citation': 'Park SH, Park C, Yoo JH, Choi SM, Choi JH, Shin HH, Lee DG, Lee S, Kim J, Choi SE, Kwon YM, Shin WS. Emergence of community-associated methicillin-resistant Staphylococcus aureus strains as a cause of healthcare-associated bloodstream infections in Korea. Infect Control Hosp Epidemiol. 2009 Feb;30(2):146-55. doi: 10.1086/593953.'}, {'pmid': '20227225', 'type': 'BACKGROUND', 'citation': "Wu D, Wang Q, Yang Y, Geng W, Wang Q, Yu S, Yao K, Yuan L, Shen X. Epidemiology and molecular characteristics of community-associated methicillin-resistant and methicillin-susceptible Staphylococcus aureus from skin/soft tissue infections in a children's hospital in Beijing, China. Diagn Microbiol Infect Dis. 2010 May;67(1):1-8. doi: 10.1016/j.diagmicrobio.2009.12.006. Epub 2010 Mar 12."}]}, 'descriptionModule': {'briefSummary': 'Given that the Emergency Department (ED) has become the entry way for large populations of patients into the health care system, a strategy of sampling MRSA isolates in ED populations and merging this information with patient-level data may present a window to hypothesize and investigate CA-MRSA transmission within the community and its impact on hospital-acquired infections.', 'detailedDescription': "Prospective cross-sectional study involving 500 patients enrolled over a one year period at the UFHealth Shands Hospital's Adult and Pediatric Emergency Department. The collected information will serve as pilot data for a future large comprehensive multi-site study.\n\nPatients will have a wound culture and a nasal swab obtained as part of the study, which will be assessed for MRSA isolates using next-generation whole genome sequencing. The principal investigator or PI designee will also survey participants and review hospital records."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection (SSTI), which can be sampled for culture and sensitivity testing', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or Legally Authorized Representative (LAR) must have voluntarily signed an Institutional Review Board-approved informed consent form before initiation of any study procedures\n* Patient presents with an acute abscess or a non-post-operative skin/soft tissue infection\n* Patient presents through the UFHealth Shands Emergency Department\n\nExclusion Criteria:\n\n* Patients who are employed by UFHealth and provide direct patient care\n* Patients who have previously been enrolled in the study\n* Patients who are not suitable for the study in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT02363166', 'briefTitle': 'Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Molecular Epidemiology and Phylodynamic and Phylogeographic Analysis of Community-associated Methicillin-resistant Staphylococcus Aureus (CA-MRSA) Transmission: An Emergency Department Population Sampling Strategy', 'orgStudyIdInfo': {'id': 'IRB201400426'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Abscess Group', 'description': 'Adults and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection, which can be sampled for culture and sensitivity testing will be recruited.', 'interventionNames': ['Other: Acute Abscess Group']}], 'interventions': [{'name': 'Acute Abscess Group', 'type': 'OTHER', 'description': 'Samples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection.', 'armGroupLabels': ['Acute Abscess Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Joseph A Tyndall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}