Clinical trial NCT06594250: Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Official title: Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacteria Infection Mechanism
Keywords: Staphylococcus aureus bacteremia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed description: Long considered an extracellular bacterium, the investigators now know that S. aureus can have an intracellular reservoir. This was initially described in situations of infection (bone infections, vascular infections) and more recently in situations of nasal carriage without associated infection. Among S. aureus carriers, between 15% and 30% have an intracellular reservoir of this bacterium, depending on the study, in patients with no S. aureus infection. For S. aureus carriers with S. aureus infection, there are no data in the literature. The clinical significance of this intracellular reservoir in a carrier situation is currently unknown. The study team was able to demonstrate in vitro that this reservoir was not affected by the mupirocin used in decolonization, and preliminary results suggest that in vivo this reservoir may also be associated with decolonization failure.

Moreover, in vitro, it has been suggested that S. aureus may act on autophagy to promote intracellular survival. Is the intracellular reservoir more frequent in patients with S. aureus bacteremia? Is it associated with a poorer prognosis in S. aureus bacteremia? Is it associated with the production of certain S. aureus intracellular persistence factors? Is it associated with a slowdown in autophagic flow in nasal cells or phagocytes? These questions remain unanswered to this day.

To explore these questions, the investigators 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). They 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Antibiotic therapy in place for more than 5 days at the time of inclusion
* Nasal decolonization of S. aureus within 12 months
* Pregnant or breast-feeding women
* Patients under guardianship
* Polymicrobial bacteremia including S. aureus

Primary outcomes:
measure: Number of intracellular S. aureus carriers at nasal level research
timeFrame: At inclusion
Secondary outcomes:
measure: Number of intracellular S. aureus carriers at nasal level research
timeFrame: Day 7
measure: In-hospital mortality rate (%)
timeFrame: Month 1
measure: Mean duration of S. aureus bacteremia (Day)
timeFrame: Month 1
measure: Average number of secondary localizations of S. aureus bacteremia
timeFrame: Month 2
measure: Average length of stay in hospital for S. aureus bacteremia (Day)
timeFrame: Month 1
measure: Proportion of nasal S. aureus carriers still carriers at the end of treatment for bacteremia (%)
timeFrame: Month 1
measure: Proportion of nasal S. aureus carriers still carriers one year after the end of treatment for bacteremia (%)
timeFrame: Month 12
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de St Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Elisabeth BOTELHO-NEVERS, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU SAINT-ETIENNE
name: Léo SAUVAT, MD
role: STUDY_CHAIR
References: