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

NCT04469348 | Completed

• 2 other identifiers: 19CH0502020-A00321-38
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Months: 0

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

  Months: 0

• cytokine concentration

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

• concentration of ICAM-1 in S. Aureus

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

Study Arms (1)

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

Diagnostic Test: nasal swab

Interventions

nasal swab DIAGNOSTIC_TEST

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

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Paul Verhoeven, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: October 18, 2021
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)