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Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus (I3COSa)

Primary Purpose

Healthy

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

nasal swab

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring Staphylococcus aureus, ICAM-1, nasal cells, S. aureus, nasal swab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

CHU de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy volunteers

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measurement of the expression of the genes (mRNA dosage) involved in IL-1 beta secretion

Measure by rt-qPCR technique.

Measurement of the expression of the genes (mRNA dosage) involved in activation of autophagy

Measure by rt-qPCR technique.

cytokine concentration

Measure by analysis of nasal swab.

concentration of ICAM-1 in S. Aureus

Measure by analysis of nasal swab.

Full Information

NCT ID

NCT04469348

First Posted

July 9, 2020

Last Updated

November 29, 2022

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT04469348

Brief Title

Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus

Acronym

I3COSa

Official Title

Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 18, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

Staphylococcus aureus, ICAM-1, nasal cells, S. aureus, nasal swab

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

157 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteers

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

nasal swab

Intervention Description

nasal swab will be performed to analysis biological markers at every visit.

Primary Outcome Measure Information:

Title

level of ICAM-1 expression in nasal cells

Description

Compare the level of ICAM-1 expression in nasal cells with and without the presence of intracellular Staphylococcus aureus

Time Frame

Months: 0

Secondary Outcome Measure Information:

Title

Measurement of the expression of the genes (mRNA dosage) involved in IL-1 beta secretion

Description

Measure by rt-qPCR technique.

Time Frame

Months: 0

Title

Measurement of the expression of the genes (mRNA dosage) involved in activation of autophagy

Description

Measure by rt-qPCR technique.

Time Frame

Months: 0

Title

cytokine concentration

Description

Measure by analysis of nasal swab.

Time Frame

Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Title

concentration of ICAM-1 in S. Aureus

Description

Measure by analysis of nasal swab.

Time Frame

Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Verhoeven, MD

Phone

(0)4 77 82 92 28

Ext

+33

paul.verhoeven@chu-st-etienne.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Florence RANCON, CRA

Phone

(0)4 77 82 94 58

Ext

+33

florence.rancon@chu-st-etienne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Verhoeven, MD

Organizational Affiliation

CHU SAINT-ETIENNE

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Saint-Etienne

City

Saint-Étienne

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Verhoeven, MD

First Name & Middle Initial & Last Name & Degree

Bruno Pozzetto, MD - PhD

First Name & Middle Initial & Last Name & Degree

Philippe Berthelot, MD - PhD

First Name & Middle Initial & Last Name & Degree

Elisabeth Botelho-Nevers, MD - PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus

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