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Clinical Trials/NCT02363166
NCT02363166
Completed
Not Applicable

Molecular Epidemiology and Phylodynamic and Phylogeographic Analysis of Community-associated Methicillin-resistant Staphylococcus Aureus (CA-MRSA) Transmission: An Emergency Department Population Sampling Strategy

University of Florida1 site in 1 country575 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Methicillin-Resistant Staphylococcus Aureus
Sponsor
University of Florida
Enrollment
575
Locations
1
Primary Endpoint
Strain Relatedness Identification Through Phylogenetic Analysis
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
April 4, 2018
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation(6 Months)
  • Strain Transmission Through Analysis of Genetic Clustering(1 year)
  • Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI)(6 Months)

Study Sites (1)

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