S. Aureus, Skin and Soft Tissue Infections

NCT02796742 | Completed

• 1 other identifier: 69HCL16_0338
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin and Soft Tissue Infections (SSTIs)

Keywords

SSTIs; Methicillin-resistant Staphylococcus aureus (MRSA); Methicillin susceptible Staphylococcus aureus (MSSA); the toxin Panton-Valentine Leukocidin (PVL); Emergency Departments

Outcome Measures

Primary Outcomes (1)

• Prevalence of staphylococcus aureus strains among all clinical SSTIs collected during the study.

  after a 3 month period

Secondary Outcomes (2)

• 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

Study Arms (4)

Group MSSA

Other: Collecting samples from all patients presenting with SSTIs requiring drainage

Group MRSA

Other: Collecting samples from all patients presenting with SSTIs requiring drainage

Group PVL-negative strains

Other: Collecting samples from all patients presenting with SSTIs requiring drainage

Group PVL-positive strains

Other: Collecting samples from all patients presenting with SSTIs requiring drainage

Interventions

Collecting samples from all patients presenting with SSTIs requiring drainage OTHER

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; Group MSSA; Group PVL-negative strains; Group PVL-positive strains

Eligibility Criteria

• Age: 1 Day - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

National Reference Center for Staphylococci, 59 boulevard Pinel

Bron, 69677, France

Location

Related Publications (1)

• 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.

  PMID: 16914702 BACKGROUND

MeSH Terms

Conditions

Soft Tissue Infections; Emergencies

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François Vandenesch, Pr

  National Reference Center for Staphylococci

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 13, 2016
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

FR (1)