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Staphylococcus Aureus Nasal Carriage (SANAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796690
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date June 7, 2016
First Posted Date June 13, 2016
Last Update Posted Date June 13, 2016
Study Start Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2016)
Rate of nasal carriage of Staphylococcus aureus (SA) among employees of a teaching hospital in Lyon-France according to professional exposure and compliance with good hygiene practices. [ Time Frame: after 2 days ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 7, 2016)
  • Prevalence of nasal carriage of Staphylococcus aureus (SA) methicillin susceptible (MSSA) or methicillin resistant (MRSA) among employees of a teaching hospital in Lyon-France. [ Time Frame: after 2 days ]
  • Presence or not of nasal carriage of Staphylococcus aureus (SA) among employees of a teaching hospital in Lyon-France at particular conditions as long medication intake and overweight. [ Time Frame: after 2 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Staphylococcus Aureus Nasal Carriage
Official Title Staphylococcus Aureus Nasal Carriage Among Technical Staff of a Teaching Hospital: An Unexpected Group at Risk of Colonization
Brief Summary

The repeated exposition to S. aureus is considered as a determining factor of acquisition of the nasal colonization. The healthcare professionals are regularly in touch with this pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was the object of several studies but little took into account the respect for the rules of good hygienic practice. The results of our previous study carried out during the international congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association between the work in a hospital environment and the increase of the risk of nasal carriage. On the contrary, the use of the hydro-alcoholic solutions had a protective effect against this carriage. However, sized of the health care population of our study was limited.

The goal of this study is to confirm our previous results on a larger cohort of healthcare professionals. The main objective is to estimate the prevalence of nasal carriage according to the professional category and by taking into account the degree of conformity with good hygiene practices including the use of hydro-alcoholic solutions.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Employees of a teaching hospital in Lyon-France
Condition Nasal Carriage of Staphylococcus Aureus
Intervention Other: nasal swabs will be collected
After formal consent, nasal swabs are collected for each participant. SA nasal carriage and its susceptibility to methicillin is determined using a rapid PCR technique (GenExpert, Cepheid). Each participant is asked to complete a short questionnaire regarding some demographic variables, smoking habits, long-term medication, sector of activity, and direct manipulation of the pathogen.
Study Groups/Cohorts
  • Group Methicillin susceptible Staphylococcus aureus (MSSA)
    Intervention: Other: nasal swabs will be collected
  • Group methicillin resistant Staphylococcus aureus (MRSA)
    Intervention: Other: nasal swabs will be collected
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 7, 2016)
310
Original Actual Enrollment Same as current
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- Employees with Consent.

Exclusion Criteria:

- Presence of contraindicating medical conditions preventing nasal swabing

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02796690
Other Study ID Numbers 69HCL16_0337
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: François Vandenesch, Pr National Reference Center for Staphylococci
PRS Account Hospices Civils de Lyon
Verification Date June 2016