S. Aureus, Skin and Soft Tissue Infections (SSTIs)

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

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.

Study Overview

• Status: Completed
• Conditions: Skin and Soft Tissue Infections (SSTIs)
• Intervention / Treatment: Other: Collecting samples from all patients presenting with SSTIs requiring drainage

• Study Type: Observational
• Enrollment (Actual): 249

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • National Reference Center for Staphylococci, 59 boulevard Pinel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 98 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group MSSA	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.
Group MRSA	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.
Group PVL-negative strains	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.
Group PVL-positive strains	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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. doi: 10.1056/NEJMoa055356.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 7, 2016
• First Posted (Estimate): June 13, 2016

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: SSTIs; Methicillin-resistant Staphylococcus aureus (MRSA); Methicillin susceptible Staphylococcus aureus (MSSA); the toxin Panton-Valentine Leukocidin (PVL); Emergency Departments
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Soft Tissue Infections
• Other Study ID Numbers: 69HCL16_0338