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

Methicillin-Resistant Staphylococcus Aureus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02363166
• Other study ID #: IRB201400426
• Status: Recruiting
• Start date: August 2015
• Est. completion date: February 5, 2025

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: Joseph A Tyndall, MD
• Phone: 352-265-5911
• Email: tyndall[@]ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 575
• Est. completion date: February 5, 2025
• Est. primary completion date: February 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

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

Related Conditions & MeSH terms

• Methicillin-Resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

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

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Strain Transmission Through Analysis of Genetic Clustering	Phlyodynamic analysis of MRSA transmission course by strain	1 year
Secondary	Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation	To determine patient-level characteristics, including social and medical history, associated with a presentation related to SSTIs.	6 Months
Secondary	Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI)	Compare patient-level characteristics and phylogenetic clustering between pediatric and adult patients presenting with SSTIs.	6 Months