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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: nasal swab

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 Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers; 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	Diagnostic test: nasal swab; nasal swab will be performed to analysis biological markers at every visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Months: 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the expression of the genes (mRNA dosage) involved in IL-1 beta secretion	Measure by rt-qPCR technique.	Months: 0
Measurement of the expression of the genes (mRNA dosage) involved in activation of autophagy	Measure by rt-qPCR technique.	Months: 0
cytokine concentration	Measure by analysis of nasal swab.	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.	Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Paul Verhoeven, MD, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; S. aureus; ICAM-1; nasal cells; nasal swab
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 19CH050; 2020-A00321-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No