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

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ClinicalTrials.gov Identifier: NCT02796742
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Skin and Soft Tissue Infections (SSTIs) Other: Collecting samples from all patients presenting with SSTIs requiring drainage

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Study Type : Observational
Actual Enrollment : 249 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of S. Aureus Among Patients Presenting With Skin and Soft Tissue Infections: a Multi-centre Pilot Study in Europe
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

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.




Primary Outcome Measures :
  1. Prevalence of staphylococcus aureus strains among all clinical SSTIs collected during the study. [ Time Frame: after a 3 month period ]

Secondary Outcome Measures :
  1. Percentage of MSSA, MRSA strains among all clinical SSTIs collected during the study [ Time Frame: after a 3 month period ]
  2. Percentage of PVL-positive strains among all clinical SSTIs collected during the study [ Time Frame: after a 3 month period ]


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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796742


Locations
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France
National Reference Center for Staphylococci, 59 boulevard Pinel
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: François Vandenesch, Pr National Reference Center for Staphylococci

Publications:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02796742     History of Changes
Other Study ID Numbers: 69HCL16_0338
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016

Keywords provided by Hospices Civils de Lyon:
SSTIs
Methicillin-resistant Staphylococcus aureus (MRSA)
Methicillin susceptible Staphylococcus aureus (MSSA)
the toxin Panton-Valentine Leukocidin (PVL)
Emergency Departments

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Soft Tissue Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents