Staphylococcal InfectionsSREENSTAPH2NCT02595112
Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery
A study testing Staphylococcus aureus carriage in people with Staphylococcal Infections, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium. Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Staphylococcus aureus carriage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2016to 5 Sep 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing otorhinolaryngologic surgery, unknown Staphylococcus aureus carriage state
- Patient affiliated to French Social Security
- Written consent
Who cannot join
- Antibiotherapy or infectious episode during the month prior enrollment
- coagulation disorder
- neoplasia of the nasal cavity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery. A Monocentric Study
Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium. Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. This study is aimed at evaluating the relationship between Staphylococcus aureus strains colonizing the vestibulum nasi, the sphenoethmoidal recess and the nasopharynx.
- Conditions
- Staphylococcal Infections
- Being tested
- Staphylococcus aureus carriage
- Keywords
- staphylococcal infections, nasal carriage, nasal cavity, Staphylococcus aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staphylococcus aureus carriageOther
Vestibulum nasi and posterior nasal cavity sampling with swabs and posterior nasal cavity sampling by endoscopic procedure during otorhinolaryngologic surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing otorhinolaryngologic surgery | Experimental | Staphylococcus aureus carriage is measured in the vestibulum nasi and posterior nasal cavity. Posterior nasal cavity is measured during endoscopic procedure. Receives: Other: Staphylococcus aureus carriage |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with staphylococcus aureus carriage in the posterior nasal cavity
Measured: Day 1
Secondary outcomes (1)
number of patients with staphylococcus aureus carriage in the vestibulum nasi
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start4 Feb 2016
- Primary completion4 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Verhoeven, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595112
- Sponsor's protocol ID
- 1508154
- Other IDs
- 2015-A01620-49
- Acronym
- SREENSTAPH2
- Status last verified
- Dec 2017
- First submitted
- 2 Nov 2015
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery. A Monocentric Study
- ClinicalTrials.gov ID
- NCT02595112
- Acronym / sponsor ID
- SREENSTAPH2 / 1508154
- Conditions
- Staphylococcal Infections
- Keywords
- staphylococcal infections, nasal carriage, nasal cavity, Staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 3 Nov 2015 (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.
Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium. Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. This study is aimed at evaluating the relationship between Staphylococcus aureus strains colonizing the vestibulum nasi, the sphenoethmoidal recess and the nasopharynx.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing otorhinolaryngologic surgery | Experimental | Other: Staphylococcus aureus carriageStaphylococcus aureus carriage is measured in the vestibulum nasi and posterior nasal cavity. Posterior nasal cavity is measured during endoscopic procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing otorhinolaryngologic surgery, unknown Staphylococcus aureus carriage state
- Patient affiliated to French Social Security
- Written consent
Key exclusion criteria (3 listed)
- Antibiotherapy or infectious episode during the month prior enrollment
- coagulation disorder
- neoplasia of the nasal cavity
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 |
|---|---|---|
| Staphylococcus aureus carriageVestibulum nasi and posterior nasal cavity sampling with swabs and posterior nasal cavity sampling by endoscopic procedure during otorhinolaryngologic surgery | Other | Patient undergoing otorhinolaryngologic surgery |
Primary outcome
number of patients with staphylococcus aureus carriage in the posterior nasal cavity
Time frame: Day 1
1 secondary outcome
number of patients with staphylococcus aureus carriage in the vestibulum nasi
Time frame: Day 1
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 30 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Paul Verhoeven principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staphylococcus aureus carriage in people with Staphylococcal Infections, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 3 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 30 Jan 2018. 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?
number of patients with staphylococcus aureus carriage in the posterior nasal cavity (time frame: Day 1). 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 30 Jan 2018.