NCT02363166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

February 9, 2015

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Strain Relatedness Identification Through Phylogenetic Analysis

    Molecular (spa-typing) and genomic (WGS) relatedness of MRSA strains in isolates in ED populations presenting with SSTIs.

    1 Hour

Secondary Outcomes (3)

  • Strain Transmission Through Analysis of Genetic Clustering

    1 year

  • Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation

    6 Months

  • Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI)

    6 Months

Study Arms (1)

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

Interventions

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

Acute Abscess Group

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Gainesville, Florida, 32608, United States

Location

Related Publications (5)

  • 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: 19224749BACKGROUND
  • 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: 19224756BACKGROUND
  • 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: 23712667BACKGROUND
  • 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: 19128184BACKGROUND
  • 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.

    PMID: 20227225BACKGROUND

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.

Study Officials

  • Joseph A Tyndall, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

August 1, 2015

Primary Completion

April 4, 2018

Study Completion

April 4, 2018

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations