NCT Number: NCT06594250
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Saint-Etienne, 42055, France
Location status: Recruiting
Amadine GAGNEUX-BRUNON, MD-PhD
SUB_INVESTIGATOR
Elisabeth BOTELHO-NEVERS, MD-PhD
PRINCIPAL_INVESTIGATOR
Léo SAUVAT, MD
SUB_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nasal swab to detect nasal carriage of S. aureus
Peripheral venous sampling to collect peripheral blood mononuclear cells.
Antibiotic treatment for bacteremia (+/- 1 month), in all patients with S. aureus
A new nasal swab will be taken using the same technique, to see whether or not the carriage persists
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.
Time frame: At inclusion
Number of intracellular S. aureus carriers at nasal level research in patients with S. aureus bacteremia associated or not
Time frame: Day 7
Time frame: Month 1
In-hospital mortality rate directly related to infection (septic shock, multivisceral failure, death during surgical management related to infection) during bacteremia
Time frame: Month 1
Time frame: Month 2
Clinically diagnosed, or on examination carried out as part of the extension work-up performed as part patient management (Scan, echocardiography, scintigraphy, etc.)
Time frame: Month 1
Time frame: Month 1
Time frame: Month 12
Contact information is provided by the study sponsor or research team.
Amandine Gagneux-Brunon, MD-PhD
CONTACT
(0)477120356 ext. +33
Elisabeth BOTELHO-NEVERS, MD-PhD
CONTACT
(0)477120764 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
Acronym: RISTA
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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