Staphylococcus AureusPSARM-SNCT01148485
Community-acquired Methicillin-Resistant Staphylococcus Aureus Carriage Among Athletes
An observational study of Staphylococcus Aureus, run by University Hospital, Limoges.
Trial summary
There are only very few data about the prevalence of CA-MRSA in France and no in athletes. In USA, the clone USA300 is widely disseminated and in Europe the clone ST80 predominates. The aim of the study was to study the carriage of S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- Nasal, throat, inguinal and skin lesions swab samples will be performed
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Athletes of Limousin practicing sport.
Who may be able to join
- adult patients (over 18),
- belonging to a sport club of Limousin, practicing rugby, wrestling, basket-ball, volley-ball, hand-ball, fence, martial art, football, weight lifting, and base-ball.
- Patient having signed in a free way and lit his consent to participate in this study
Who cannot join
- clinical information questionnaire not possible to fill,
- swab sample not possible to realize.
About this study
Official title: Community-acquired Methicillin-Resistant Staphylococcus Aureus Carriage Among Athletes: a Study in Limousin. : CA-MRSA
There are only very few data about the prevalence of CA-MRSA in France and no in athletes. In USA, the clone USA300 is widely disseminated and in Europe the clone ST80 predominates. The aim of the study was to study the carriage of S. aureus in athletes in a French county (Limousin) and to evaluate the proportion of CA-MRSA. The athletes will be met during their training, each one will fill-in a clinical information questionnaire. Nasal, throat, inguinal and skin lesions swab samples will be performed. The antibiotic susceptibility profile of the Staphyloccocus aureus strains isolated will be performed as well as the detection of the PVL gene. Strains will also be typed by different molecular methods (PGFE (Pulsed Gel Field Electrophoresis), SCCmec type (Staphylococcal Chromosome Cassette mec), and MLST (MultiLocus Sequence Typing)). The CIC (Clinical Investigation Center) of the Limoges University Hospital will be in charge of the inclusions of the athletes. The sample analysis will be centralized and performed at the Laboratory of Bacteriology of the Limoges University Hospital. A Clinical Research Officer of the Limoges University Hospital will be in charge of the survey of the study and will organize monthly meetings with all the participants of the study.
- Conditions
- Staphylococcus Aureus
- Being tested
- Nasal, throat, inguinal and skin lesions swab samples will be performed
- Keywords
- - Staphylococcus aureus Carriage among Athletes
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal, throat, inguinal and skin lesions swab samples will be performedOther
Nasal, throat, inguinal and skin lesions swab samples will be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Methicillin-Resistant Staphylococcus aureus in the samples.
An athlete is defined as a carrier if at least one strain of Staphylococcus aureus is isolated from one of these samples.
A MRSA carrier is defined if the resistance to methicillin has been found for the S. aureus strain isolated in the patient.
Measured: 1 year
Secondary outcomes (1)
Comparison of the MRSA prevalence in athletes according to the sport
Comparison of the MRSA prevalence in athletes according to the sport.A strain is considered as PVL positive if the gene encoding the PVL was detected by PCR.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionDec 2011
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 Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148485
- Sponsor's protocol ID
- I09016
- Acronym
- PSARM-S
- Status last verified
- Jun 2010
- First submitted
- 16 Jun 2010
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Couve-Deacon E, Postil D, Barraud O, Duchiron C, Chainier D, Labrunie A, Pestourie N, Preux PM, Francois B, Ploy MC. Staphylococcus Aureus Carriage in French Athletes at Risk of CA-MRSA Infection: a Prospective, Cross-sectional Study. Sports Med Open. 2017 Aug 16;3(1):28. doi: 10.1186/s40798-017-0094-z.
PubMed 28815486
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-acquired Methicillin-Resistant Staphylococcus Aureus Carriage Among Athletes: a Study in Limousin. : CA-MRSA
- ClinicalTrials.gov ID
- NCT01148485
- Acronym / sponsor ID
- PSARM-S / I09016
- Conditions
- Staphylococcus Aureus
- Keywords
- - Staphylococcus aureus Carriage among Athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jun 2010 (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.
There are only very few data about the prevalence of CA-MRSA in France and no in athletes. In USA, the clone USA300 is widely disseminated and in Europe the clone ST80 predominates. The aim of the study was to study the carriage of S. aureus in athletes in a French county (Limousin) and to evaluate the proportion of CA-MRSA. The athletes will be met during their training, each one will fill-in a clinical information questionnaire. Nasal, throat, inguinal and skin lesions swab samples will be performed. The antibiotic susceptibility profile of the Staphyloccocus aureus strains isolated will be performed as well as the detection of the PVL gene. Strains will also be typed by different molecular methods (PGFE (Pulsed Gel Field Electrophoresis), SCCmec type (Staphylococcal Chromosome Cassette mec), and MLST (MultiLocus Sequence Typing)). The CIC (Clinical Investigation Center) of the Limoges University Hospital will be in charge of the inclusions of the athletes. The sample analysis will be centralized and performed at the Laboratory of Bacteriology of the Limoges University Hospital. A Clinical Research Officer of the Limoges University Hospital will be in charge of the survey of the study and will organize monthly meetings with all the participants of the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Athletes of Limousin practicing sport.
Key inclusion criteria (3 listed)
- adult patients (over 18),
- belonging to a sport club of Limousin, practicing rugby, wrestling, basket-ball, volley-ball, hand-ball, fence, martial art, football, weight lifting, and base-ball.
- Patient having signed in a free way and lit his consent to participate in this study
Key exclusion criteria (2 listed)
- clinical information questionnaire not possible to fill,
- swab sample not possible to realize.
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 |
|---|---|---|
| Nasal, throat, inguinal and skin lesions swab samples will be performedNasal, throat, inguinal and skin lesions swab samples will be performed | Other | – |
Primary outcome
Presence of Methicillin-Resistant Staphylococcus aureus in the samples.
Time frame: 1 year
An athlete is defined as a carrier if at least one strain of Staphylococcus aureus is isolated from one of these samples. A MRSA carrier is defined if the resistance to methicillin has been found for the S. aureus strain isolated in the patient.
1 secondary outcome
Comparison of the MRSA prevalence in athletes according to the sport
Time frame: 1 year
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 1 Nov 2013.
- Derived from this study: PubMed 28815486Couve-Deacon E, Postil D, Barraud O, Duchiron C, Chainier D, Labrunie A, Pestourie N, Preux PM, Francois B, Ploy MC. Staphylococcus Aureus Carriage in French Athletes at Risk of CA-MRSA Infection: a Prospective, Cross-sectional Study. Sports Med Open. 2017 Aug 16;3(1):28. doi: 10.1186/s40798-017-0094-z.
Related trials for Staphylococcus Aureus
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus, run by University Hospital, Limoges.
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 3 inclusion and 2 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Presence of Methicillin-Resistant Staphylococcus aureus in the samples. (time frame: 1 year). 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 NCT01148485, 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 1 Nov 2013.