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

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT02363166
Collaborator
(none)
575
1
78.1
7.4

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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 :
Aug 1, 2015
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Strain Relatedness Identification Through Phylogenetic Analysis [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 [1 year]

    Phlyodynamic analysis of MRSA transmission course by strain

  2. Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation [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) [6 Months]

    Compare patient-level characteristics and phylogenetic clustering between pediatric and adult patients presenting with SSTIs.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 UF Health Gainesville Florida United States 32608

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Joseph A Tyndall, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT02363166
Other Study ID Numbers:
  • IRB201400426
First Posted:
Feb 13, 2015
Last Update Posted:
Jun 7, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2021