Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia

NCT06594250 | Recruiting

• 2 other identifiers: 20CH0252020-A02692-37
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

Staphylococcus aureus bacteremia is a serious infection associated with a high mortality rate (with or without associated infective endocarditis (IE)), long hospital stays and multiple complications, due to the terrain in which it occurs and its secondary localization. They may be community-acquired or healthcare-associated infections. Being a carrier of S. aureus is a known risk factor for S. aureus bacteremia. Although several mucosal sites of carriage have been described, screening for carriage is most often carried out at the nasal level, both for reasons of simplicity and because it is the predominant site of carriage of this bacterium. However, S. aureus carriage is a frequent occurrence, affecting around 1/3 of the general population.

Conditions

Bacteria Infection Mechanism

Keywords

Staphylococcus aureus bacteremia

Outcome Measures

Primary Outcomes (1)

• Number of intracellular S. aureus carriers at nasal level research

  Number of intracellular S. aureus carriers at nasal level research in patients with S. aureus bacteremia associated or not

  At inclusion

Secondary Outcomes (7)

• Number of intracellular S. aureus carriers at nasal level research

  Day 7

• In-hospital mortality rate (%)

  Month 1

• Mean duration of S. aureus bacteremia (Day)

  Month 1

• Average number of secondary localizations of S. aureus bacteremia

  Month 2

• Average length of stay in hospital for S. aureus bacteremia (Day)

  Month 1

Study Arms (2)

Experimental group

Experimental group comprising patients with S. aureus bacteremia with or without IE

Diagnostic Test: Nasal swab; Biological: Venous sampling; Biological: Antibiotic treatment; Device: Nasal swab; Biological: Intracellular reservoir test

Control group

Control group comprising patients with bacteremia with a pathogenic bacterial species other than S. aureus with or without IE.

Diagnostic Test: Nasal swab; Biological: Venous sampling; Biological: Antibiotic treatment; Device: Nasal swab; Biological: Intracellular reservoir test

Interventions

Nasal swab DIAGNOSTIC_TEST

Nasal swab to detect nasal carriage of S. aureus

Control group; Experimental group

Venous sampling BIOLOGICAL

Peripheral venous sampling to collect peripheral blood mononuclear cells.

Control group; Experimental group

Antibiotic treatment BIOLOGICAL

Antibiotic treatment for bacteremia (+/- 1 month), in all patients with S. aureus

Control group; Experimental group

Intracellular reservoir test BIOLOGICAL

In the event of positive carriage, a new intracellular reservoir test will be performed. A search for relapse (new S. aureus infection) or recurrence (S. aureus bacteremia if the 1st bacteremia was due to another pathogen) will be carried out.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at St-Etienne University Hospital with bacteremia with or without IE. Patients will be assigned to the experimental group in the case of S. aureus bacteremia (whether or not associated with an IE), or to the control group in the case of bacteremia caused by a pathogenic bacterium other than S. aureus (whether or not associated with an IE).

You may qualify if:

• Bacteremia
• Patient affiliated or entitled to a social security plan
• Patient who has signed a consent form to participate in the study.

You may not qualify if:

• Nasal decolonization of S. aureus within 12 months
• Pregnant or breast-feeding women
• Patients under guardianship
• Polymicrobial bacteremia including S. aureus

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de St Etienne

Saint-Etienne, 42055, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We plan to conduct a study to assess the frequency of the intracellular S. aureus reservoir (within carriers) in S. aureus bacteremia and in bacteremia to another pathogen (control group). We would also like to study the impact of this reservoir on the persistence of carriage and prognosis (death, duration of bacteremia, length of stay, presence of secondary localizations of bacteremia or endocarditis in the case of S. aureus bacteremia).

Study Officials

• Elisabeth BOTELHO-NEVERS, MD-PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

• Léo SAUVAT, MD

  CHU SAINT-ETIENNE

  STUDY CHAIR

Central Study Contacts

Elisabeth BOTELHO-NEVERS, MD-PhD

CONTACT

(0)477120764; elisabeth.botelho-nevers@chu-st-etienne.fr

Amandine Gagneux-Brunon, MD-PhD

CONTACT

(0)477120356; amandine.gagneux-brunon@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 2, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)