HealthyI3COSaNCT04469348
Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus
A study testing nasal swab in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
An inflammatory state of the nasal cells (very close to keratinocytes) could favour the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- nasal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2021to 9 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject affiliated to a social security scheme or entitled person
- Subject who received informed information about the study et signed consent
- Adult subject (≥18ans)
- Healthy Volunteer
Who cannot join
- Subject undergoing antibiotic treatment or having received antibiotic treatment (oral, IV or local) in the month prior to inclusion
- Subject with a major haemostasis disorder or anticoagulant treatment contraindicated for surgery
- Subject with a pathology increasing the nasal carriage of S. aureus (chronic furunculosis, diabetes, HIV infection, chronic rhinosinusitis)
- Subject under guardianship or trusteeship
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
An inflammatory state of the nasal cells (very close to keratinocytes) could favour the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.
Staphylococcus aureus is a commensal bacterium of the skin and mucous membranes that colonizes approximately 2 billion people worldwide Staphylococcus aureus is also a leading cause of community and healthcare-associated infection. Staphylococcus aureus has demonstrated its ability to invade many non-professional phagocytic cell lines such as keratinocytes, osteoblasts, fibroblasts, epithelial cells and endothelial cells. During pro-inflammatory stimulation, internalization of Staphylococcus aureus into keratinocytes is mainly mediated by ICAM-1. These results suggest that, in humans, an inflammatory state of the nasal cells (very close to keratinocytes) could promote the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.
Read the detailed description
The main objective is to compare the expression level of ICAM-1 in nasal cells with and without the presence of Staphylococcus aureus.
- Conditions
- Healthy
- Being tested
- nasal swab
- Keywords
- Staphylococcus aureus, ICAM-1, nasal cells, S. aureus, nasal swab
- 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 swabDiagnostic test
nasal swab will be performed to analysis biological markers at every visit.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Healthy volunteers will be included. They will have nasal swab at the inclusion visit to detect contamination of S. Aureus.
* If contamination of S. Aureus: they will have 12 follow-up visits (1 per month)
* If no contamination of S. Aureus: their participation stops Receives: Diagnostic Test: nasal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of ICAM-1 expression in nasal cells
Compare the level of ICAM-1 expression in nasal cells with and without the presence of intracellular Staphylococcus aureus
Measured: Months: 0
Secondary outcomes (4)
Measurement of the expression of the genes (mRNA dosage) involved in IL-1 beta secretion
Measure by rt-qPCR technique.
Measured: Months: 0
Measurement of the expression of the genes (mRNA dosage) involved in activation of autophagy
Measure by rt-qPCR technique.
Measured: Months: 0
cytokine concentration
Measure by analysis of nasal swab.
Measured: Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
concentration of ICAM-1 in S. Aureus
Measure by analysis of nasal swab.
Measured: Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start18 Oct 2021
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Verhoeven, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469348
- Sponsor's protocol ID
- 19CH050
- Other IDs
- 2020-A00321-38
- Acronym
- I3COSa
- Status last verified
- May 2024
- First submitted
- 9 Jul 2020
- Last updated
- 23 May 2024
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT04469348
- Acronym / sponsor ID
- I3COSa / 19CH050
- Conditions
- Healthy
- Keywords
- Staphylococcus aureus, ICAM-1, nasal cells, S. aureus, nasal swab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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.
An inflammatory state of the nasal cells (very close to keratinocytes) could favour the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.
Staphylococcus aureus is a commensal bacterium of the skin and mucous membranes that colonizes approximately 2 billion people worldwide Staphylococcus aureus is also a leading cause of community and healthcare-associated infection. Staphylococcus aureus has demonstrated its ability to invade many non-professional phagocytic cell lines such as keratinocytes, osteoblasts, fibroblasts, epithelial cells and endothelial cells. During pro-inflammatory stimulation, internalization of Staphylococcus aureus into keratinocytes is mainly mediated by ICAM-1. These results suggest that, in humans, an inflammatory state of the nasal cells (very close to keratinocytes) could promote the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.
Detailed description
The main objective is to compare the expression level of ICAM-1 in nasal cells with and without the presence of Staphylococcus aureus.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Diagnostic Test: nasal swabHealthy volunteers will be included. They will have nasal swab at the inclusion visit to detect contamination of S. Aureus. * If contamination of S. Aureus: they will have 12 follow-up visits (1 per month) * If no contamination of S. Aureus: their participation stops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject affiliated to a social security scheme or entitled person
- Subject who received informed information about the study et signed consent
- Adult subject (≥18ans)
- Healthy Volunteer
Key exclusion criteria (5 listed)
- Subject undergoing antibiotic treatment or having received antibiotic treatment (oral, IV or local) in the month prior to inclusion
- Subject with a major haemostasis disorder or anticoagulant treatment contraindicated for surgery
- Subject with a pathology increasing the nasal carriage of S. aureus (chronic furunculosis, diabetes, HIV infection, chronic rhinosinusitis)
- Subject under guardianship or trusteeship
- Pregnant woman
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 swabnasal swab will be performed to analysis biological markers at every visit. | Diagnostic test | Healthy volunteers |
Primary outcome
level of ICAM-1 expression in nasal cells
Time frame: Months: 0
Compare the level of ICAM-1 expression in nasal cells with and without the presence of intracellular Staphylococcus aureus
4 secondary outcomes
Measurement of the expression of the genes (mRNA dosage) involved in IL-1 beta secretion
Time frame: Months: 0
Measurement of the expression of the genes (mRNA dosage) involved in activation of autophagy
Time frame: Months: 0
cytokine concentration
Time frame: Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
concentration of ICAM-1 in S. Aureus
Time frame: Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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 23 May 2024.
- 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, MD 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 nasal swab in people with Healthy, 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 4 inclusion and 5 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 23 May 2024. 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?
level of ICAM-1 expression in nasal cells (time frame: Months: 0). 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 23 May 2024.