Skin and Soft Tissue Infections (SSTIs)SSTIsNCT02796742
S. Aureus, Skin and Soft Tissue Infections
An observational study of Skin and Soft Tissue Infections (SSTIs), run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 100 years
- Conditions the study is for
- Skin and Soft Tissue Infections (SSTIs)
- What is being tested?
- Collecting samples from all patients presenting with SSTIs requiring drainage
- How many people
- 249 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients (adults and children) presenting to emergency department with OTHERS type of infections than SSTIs
Trial locations and contacts
1 site in 1 country.
France1 site
National Reference Center for Staphylococci, 59 boulevard Pinel
Bron, 69677
About this study
Official 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.
- Conditions
- Skin and Soft Tissue Infections (SSTIs)
- Being tested
- Collecting samples from all patients presenting with SSTIs requiring drainage
- Keywords
- SSTIs, Methicillin-resistant Staphylococcus aureus (MRSA), Methicillin susceptible Staphylococcus aureus (MSSA), the toxin Panton-Valentine Leukocidin (PVL), Emergency Departments
- Medical subject headings
- Soft Tissue Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting samples from all patients presenting with SSTIs requiring drainageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group MSSA | Not described Receives: Other: Collecting samples from all patients presenting with SSTIs requiring drainage | |
| Group MRSA | Not described Receives: Other: Collecting samples from all patients presenting with SSTIs requiring drainage | |
| Group PVL-negative strains | Not described Receives: Other: Collecting samples from all patients presenting with SSTIs requiring drainage | |
| Group PVL-positive strains | Not described Receives: Other: Collecting samples from all patients presenting with SSTIs requiring drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of staphylococcus aureus strains among all clinical SSTIs collected during the study.
Measured: after a 3 month period
Secondary outcomes (2)
Percentage of MSSA, MRSA strains among all clinical SSTIs collected during the study
Measured: after a 3 month period
Percentage of PVL-positive strains among all clinical SSTIs collected during the study
Measured: after a 3 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin and Soft Tissue Infections (SSTIs)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Vandenesch, Pr, Principal investigator, National Reference Center for Staphylococci
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796742
- Sponsor's protocol ID
- 69HCL16_0338
- Acronym
- SSTIs
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16914702
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of S. Aureus Among Patients Presenting With Skin and Soft Tissue Infections: a Multi-centre Pilot Study in Europe
- ClinicalTrials.gov ID
- NCT02796742
- Acronym / sponsor ID
- SSTIs / 69HCL16_0338
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients (adults and children) presenting to emergency department with OTHERS type of infections than SSTIs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting samples from all patients presenting with SSTIs requiring drainageThe 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. | Other | Group MRSA, Group MSSA, Group PVL-negative strains, Group PVL-positive strains |
Primary outcome
Prevalence of staphylococcus aureus strains among all clinical SSTIs collected during the study.
Time frame: after a 3 month period
2 secondary outcomes
Percentage of MSSA, MRSA strains among all clinical SSTIs collected during the study
Time frame: after a 3 month period
Percentage of PVL-positive strains among all clinical SSTIs collected during the study
Time frame: after a 3 month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Background: PubMed 16914702Moran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Vandenesch, Pr principal investigator
National Reference Center for Staphylococci
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin and Soft Tissue Infections (SSTIs), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of staphylococcus aureus strains among all clinical SSTIs collected during the study. (time frame: after a 3 month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.