S. Aureus, Skin and Soft Tissue Infections

Completed

• Conditions: Skin and Soft Tissue Infections (SSTIs)
• Interventions: Other: Collecting samples from all patients presenting with SSTIs requiring drainage

• Registration Number: NCT02796742
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-06
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group PVL-negative strains	Collecting samples from all patients presenting with SSTIs requiring drainage	-
Group PVL-positive strains	Collecting samples from all patients presenting with SSTIs requiring drainage	-
Group MSSA	Collecting samples from all patients presenting with SSTIs requiring drainage	-
Group MRSA	Collecting samples from all patients presenting with SSTIs requiring drainage	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Reference Center for Staphylococci, 59 boulevard Pinel; 🇫🇷 Bron, France