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Completed

NCT Number: NCT04469348

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

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.

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Key information

Conditions

Healthy Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Staphylococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal swab

Diagnostic Test

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

Primary outcomes

  1. level of ICAM-1 expression in nasal cells

    Time frame: Months: 0

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

Secondary outcomes

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

    Time frame: Months: 0

    Measure by rt-qPCR technique.

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

    Time frame: Months: 0

    Measure by rt-qPCR technique.

  3. cytokine concentration

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

    Measure by analysis of nasal swab.

  4. concentration of ICAM-1 in S. Aureus

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

    Measure by analysis of nasal swab.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: I3COSa

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2020
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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