- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01148485
Community-acquired Methicillin-Resistant Staphylococcus Aureus Carriage Among Athletes (PSARM-S)
October 31, 2013 updated by: University Hospital, Limoges
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
300
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Athletes of Limousin practicing sport.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- clinical information questionnaire not possible to fill,
- swab sample not possible to realize.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the MRSA prevalence in athletes according to the sport
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
June 16, 2010
First Submitted That Met QC Criteria
June 21, 2010
First Posted (ESTIMATE)
June 22, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 1, 2013
Last Update Submitted That Met QC Criteria
October 31, 2013
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I09016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Staphylococcus Aureus
-
University Hospital TuebingenNot yet recruiting
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
University of SheffieldRajarata University, Sri LankaUnknown
-
NovaDigm Therapeutics, Inc.Uniformed Services University of the Health Sciences; Infectious Diseases Clinical...CompletedStaphylococcus AureusUnited States
-
Ohio State UniversityCompletedMethicillin-resistant Staphylococcus Aureus | Methicillin-Sensitive Staphylococcus Aureus InfectionUnited States
-
Todd C. Lee MD MPH FIDSANot yet recruitingStaphylococcus Aureus Bacteremia | Staphylococcus Aureus Endocarditis | Staphylococcus Aureus Septicemia | Staphylococcal SepsisCanada
-
Forest LaboratoriesCompletedStaphylococcus Aureus Bacteremia | Methicillin-resistant Staphylococcus Aureus (MRSA) BacteremiaUnited States
-
Intron Biotechnology, Inc.CompletedHealthy Volunteers | Anti-Bacterial Agents | Methicillin-Resistant Staphylococcus Aureus | Methicillin-Sensitive Staphylococcus Aureus InfectionKorea, Republic of
-
Armata Pharmaceuticals, Inc.United States Department of DefenseRecruitingBacteremia | Staphylococcus Aureus | Staphylococcus Aureus Bacteremia | Bacteremia Due to Staphylococcus Aureus | Bacteremia StaphUnited States, Australia
-
Menzies School of Health ResearchThe University of Queensland; Australasian Society for Infectious Diseases; Singapore... and other collaboratorsTerminatedMethicillin-Resistant Staphylococcus AureusAustralia, New Zealand, Israel, Singapore
Clinical Trials on Nasal, throat, inguinal and skin lesions swab samples will be performed
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaOspedale SS Giovanni e Paolo, VeneziaRecruiting
-
Nantes University HospitalCompletedPatients Receiving Animal-derived Bioprosthetic Heart ValvesFrance, Canada, Italy, Spain
-
Memorial Sloan Kettering Cancer CenterCompletedSolid TumorsUnited States