Skin and Soft Tissue Infections (SSTIs) Clinical Trial
— SSTIsOfficial title:
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.
| Status | Completed |
| Enrollment | 249 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 100 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | National Reference Center for Staphylococci, 59 boulevard Pinel | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of staphylococcus aureus strains among all clinical SSTIs collected during the study. | after a 3 month period | No | |
| Secondary | Percentage of MSSA, MRSA strains among all clinical SSTIs collected during the study | after a 3 month period | No | |
| Secondary | Percentage of PVL-positive strains among all clinical SSTIs collected during the study | after a 3 month period | No |