Community-acquired Methicillin-Resistant Staphylococcus Aureus Carriage Among Athletes

Staphylococcus Aureus Clinical Trial

— PSARM-S  

Official title:

Community-acquired Methicillin-Resistant Staphylococcus Aureus Carriage Among Athletes: a Study in Limousin. : CA-MRSA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148485
• Other study ID #: I09016
• Status: Completed
• Phase: N/A
• First received: June 16, 2010
• Last updated: October 31, 2013
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2010
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Staphylococcal Infections
• Staphylococcus Aureus

Intervention

Other:
• Nasal, throat, inguinal and skin lesions swab samples will be performed
Nasal, throat, inguinal and skin lesions swab samples will be performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	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.	1 year	No