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Completed

NCT Number: NCT02363166

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

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.

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Key information

Conditions

Methicillin-Resistant Staphylococcus Aureus

Age range

1 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute Abscess Group

Other

Samples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 13, 2015
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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