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

Healthy Clinical Trial

— I3COSa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469348
• Other study ID #: 19CH050
• Secondary ID: 2020-A00321-38
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: January 9, 2023

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Description:

The main objective is to compare the expression level of ICAM-1 in nasal cells with and without the presence of Staphylococcus aureus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Inflammation

Intervention

Diagnostic Test:
• nasal swab
nasal swab will be performed to analysis biological markers at every visit.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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