Nasal Carriage of Staphylococcus AureusSANACNCT02796690
Staphylococcus Aureus Nasal Carriage
An observational study of Nasal Carriage of Staphylococcus Aureus, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Carriage of Staphylococcus Aureus
- What is being tested?
- nasal swabs will be collected
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2014
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Employees of a teaching hospital in Lyon-France
Who may be able to join
- Employees with Consent.
Who cannot join
- Presence of contraindicating medical conditions preventing nasal swabing
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: Staphylococcus Aureus Nasal Carriage Among Technical Staff of a Teaching Hospital: An Unexpected Group at Risk of Colonization
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.
- Conditions
- Nasal Carriage of Staphylococcus Aureus
- Being tested
- nasal swabs will be collected
- Keywords
- nasal carriage, Staphylococcus aureus, good hygiene practices
- 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 swabs will be collectedOther
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 group | Role | What they receive |
|---|---|---|
| Group Methicillin susceptible Staphylococcus aureus (MSSA) | Not described Receives: Other: nasal swabs will be collected | |
| Group methicillin resistant Staphylococcus aureus (MRSA) | Not described Receives: Other: nasal swabs will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 2 days
Secondary outcomes (2)
Prevalence of nasal carriage of Staphylococcus aureus (SA) methicillin susceptible (MSSA) or methicillin resistant (MRSA) among employees of a teaching hospital in Lyon-France.
Measured: 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.
Measured: after 2 days
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 startApr 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Carriage of Staphylococcus AureusStudies 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
- Cross-sectional
- Enrolment
- 310 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
- NCT02796690
- Sponsor's protocol ID
- 69HCL16_0337
- Acronym
- SANAC
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2016
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcus Aureus Nasal Carriage Among Technical Staff of a Teaching Hospital: An Unexpected Group at Risk of Colonization
- ClinicalTrials.gov ID
- NCT02796690
- Acronym / sponsor ID
- SANAC / 69HCL16_0337
- Conditions
- Nasal Carriage of Staphylococcus Aureus
- Keywords
- nasal carriage, Staphylococcus aureus, good hygiene practices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Methicillin susceptible Staphylococcus aureus (MSSA) | – | Other: nasal swabs will be collected |
| Group methicillin resistant Staphylococcus aureus (MRSA) | – | Other: nasal swabs will be collected |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Employees of a teaching hospital in Lyon-France
Key inclusion criteria (1 listed)
- Employees with Consent.
Key exclusion criteria (1 listed)
- Presence of contraindicating medical conditions preventing nasal swabing
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 swabs will be collectedAfter 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. | Other | Group Methicillin susceptible Staphylococcus aureus (MSSA), Group methicillin resistant Staphylococcus aureus (MRSA) |
Primary outcome
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
2 secondary outcomes
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
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 13 Jun 2016.
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 Nasal Carriage of Staphylococcus Aureus, 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 13 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2016.