Clinical trial NCT02796742: S. Aureus, Skin and Soft Tissue Infections
Official title: Prevalence of S. Aureus Among Patients Presenting With Skin and Soft Tissue Infections: a Multi-centre Pilot Study in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 249
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of staphylococcus aureus strains among all clinical SSTIs collected during the study.
timeFrame: after a 3 month period
Secondary outcomes:
measure: Percentage of MSSA, MRSA strains among all clinical SSTIs collected during the study
timeFrame: after a 3 month period
measure: Percentage of PVL-positive strains among all clinical SSTIs collected during the study
timeFrame: after a 3 month period
Other outcomes:
Locations:
city: Bron
country: France
facility: National Reference Center for Staphylococci, 59 boulevard Pinel
Study officials:
affiliation: National Reference Center for Staphylococci
name: François Vandenesch, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.