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

NCT ID: NCT04469348

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-01-09

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

nasal swab

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

nasal swab

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Verhoeven, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2020-A00321-38

Identifier Type: OTHER

Identifier Source: secondary_id

19CH050

Identifier Type: -

Identifier Source: org_study_id