S. Aureus, Skin and Soft Tissue Infections

Overview

Methicillin-resistant Staphylococcus aureus (MRSA) is reported as one of the main causative pathogen of community acquired SSTIs. In the USA, high prevalence of MRSA among Skin and soft tissue infections (SSTIs) is known to be due to the spread of the USA300 clone [Moran et al. 2006]. Among S. aureus SSTIs infections in Europe, data regarding the prevalence of MRSA in SSTIs and the causative genotypes remain scarce. The paucity of literature on the prevalence of MSSA, MRSA and PVL-producing S. aureus strains in SSTI in Europe is probably due to the fact that culture and antimicrobial susceptibility testing is not a routine component of SSTI management.

Setting-up a prospective multi-centre study involving patients presenting to emergency departments with SSTIs in several European countries would allow drawing a picture on the role and the respective contribution of MSSA, MRSA and PVL-producing S. aureus strains as a cause of SSTIs. However, the roles of emergency rooms and local policies with regard to performing microbiological analysis after surgical drainage of SSTIs vary between countries.

In order to evaluate the feasibility of such multicenter European study, we aim at performing a pilot study based on few European clinical laboratories (five to seven) which will: i) evaluate the prevalence of MSSA, MRSA and S. aureus PVL-positive strains in community-acquired SSTIs; and ii) determine molecular characteristics of the isolated strains. The main objectives of this pilot study are to collect some preliminary information on the role of S. aureus in SSTIs and to determine factors that need to be harmonized or taken into consideration for the set-up a larger prospective cross-sectional study involving more European countries with several centers per country to cover different geographical areas per country.

Full Title of Study: “Prevalence of S. Aureus Among Patients Presenting With Skin and Soft Tissue Infections: a Multi-centre Pilot Study in Europe”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2015

Interventions

  • Other: Collecting samples from all patients presenting with SSTIs requiring drainage
    • The study will be conducted by microbiology laboratories. Before the start of the study, each participating laboratory will send an information letter to its corresponding emergency departments to increase vigilance of clinicians in collecting samples from all patients presenting with SSTIs; this will improve the level of inclusion. Each participating lab will also insure connection to local representation of the project for ethical clearance, collection of clinical data and SSTI specimen.

Arms, Groups and Cohorts

  • Group MSSA
  • Group MRSA
  • Group PVL-negative strains
  • Group PVL-positive strains

Clinical Trial Outcome Measures

Primary Measures

  • Prevalence of staphylococcus aureus strains among all clinical SSTIs collected during the study.
    • Time Frame: after a 3 month period

Secondary Measures

  • Percentage of MSSA, MRSA strains among all clinical SSTIs collected during the study
    • Time Frame: after a 3 month period
  • Percentage of PVL-positive strains among all clinical SSTIs collected during the study
    • Time Frame: after a 3 month period

Participating in This Clinical Trial

Inclusion Criteria

  • All patients (adults and children) presenting to emergency department with purulent skin and soft tissue infections (SSTIs) of less than one week duration are eligible

Exclusion Criteria

  • Patients (adults and children) presenting to emergency department with OTHERS type of infections than SSTIs

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fran├žois Vandenesch, Pr, Principal Investigator, National Reference Center for Staphylococci

References

Moran GJ, Krishnadasan A, Gorwitz RJ, Fosheim GE, McDougal LK, Carey RB, Talan DA; EMERGEncy ID Net Study Group. Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med. 2006 Aug 17;355(7):666-74.

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