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临床试验/NCT06594250
NCT06594250招募中不适用

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

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2024年9月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
405
试验地点
1
主要终点
Number of intracellular S. aureus carriers at nasal level research

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Experimental group

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

干预措施: Nasal swab (Device)

Experimental group

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

干预措施: Venous sampling (Biological)

Experimental group

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

干预措施: Antibiotic treatment (Biological)

Experimental group

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

干预措施: Intracellular reservoir test (Biological)

Control group

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

干预措施: Nasal swab (Device)

Control group

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

干预措施: Venous sampling (Biological)

Control group

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

干预措施: Antibiotic treatment (Biological)

Control group

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

干预措施: Intracellular reservoir test (Biological)

结局指标

主要结局

Number of intracellular S. aureus carriers at nasal level research

时间窗: At inclusion

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

次要结局

  • 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)
  • Proportion of nasal S. aureus carriers still carriers at the end of treatment for bacteremia (%)(Month 1)
  • Proportion of nasal S. aureus carriers still carriers one year after the end of treatment for bacteremia (%)(Month 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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