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Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy

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ClinicalTrials.gov Identifier: NCT02363166
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : June 13, 2023
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Methicillin-Resistant Staphylococcus Aureus Other: Acute Abscess Group

Detailed Description:

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.

Patients 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 575 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Molecular Epidemiology and Phylodynamic and Phylogeographic Analysis of Community-associated Methicillin-resistant Staphylococcus Aureus (CA-MRSA) Transmission: An Emergency Department Population Sampling Strategy
Actual Study Start Date : August 2015
Estimated Primary Completion Date : February 5, 2025
Estimated Study Completion Date : February 5, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess MRSA

Groups and Cohorts
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Group/Cohort Intervention/treatment
Acute Abscess Group
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.
 Other: Acute Abscess Group
Samples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection.


Outcome Measures
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Primary Outcome Measures :
  1. Strain Relatedness Identification Through Phylogenetic Analysis [ Time Frame: 1 Hour ]
    Molecular (spa-typing) and genomic (WGS) relatedness of MRSA strains in isolates in ED populations presenting with SSTIs.


Secondary Outcome Measures :
  1. Strain Transmission Through Analysis of Genetic Clustering [ Time Frame: 1 year ]
    Phlyodynamic analysis of MRSA transmission course by strain

  2. Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation [ Time Frame: 6 Months ]
    To determine patient-level characteristics, including social and medical history, associated with a presentation related to SSTIs.

  3. Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI) [ Time Frame: 6 Months ]
    Compare patient-level characteristics and phylogenetic clustering between pediatric and adult patients presenting with SSTIs.


Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • Patient or Legally Authorized Representative (LAR) must have voluntarily signed an Institutional Review Board-approved informed consent form before initiation of any study procedures
  • Patient presents with an acute abscess or a non-post-operative skin/soft tissue infection
  • Patient presents through the UFHealth Shands Emergency Department

Exclusion Criteria:

  • Patients who are employed by UFHealth and provide direct patient care
  • Patients who have previously been enrolled in the study
  • Patients who are not suitable for the study in the opinion of the investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363166


Contacts
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Contact: Joseph A Tyndall, MD 352-265-5911 tyndall@ufl.edu
Contact: Scott Cohen 954-326-4202 scohen211@phhp.ufl.edu

Locations
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United States, Florida
UF Health Recruiting
Gainesville, Florida, United States, 32608
Contact: Joseph A Tyndall, MD    352-265-5911    tyndall@ufl.edu   
Contact: Scott Cohen    954-326-4202    scohen211@phhp.ufl.edu   
Principal Investigator: Joseph A Tyndall, MD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Joseph A Tyndall, MD University of Florida
More Information
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Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02363166    
Other Study ID Numbers: IRB201400426
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: June 13, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections