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临床试验/NCT03685487
NCT03685487已完成不适用

Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2019年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
215
试验地点
1
主要终点
number of participants with failure of decolonization of nasal carriers of S. aureus

研究概览

简要总结

Staphylococcus aureus nasal carriage is a well-known risk factor for S. aureus surgical site infections (SSI). According to a recent study demonstrating 60% reduction risk of SSI due this bacterium after patients' screening and decolonization, recent French and WHO guidelines recommend in cardiac surgery the decolonization of nasal S. aureus carriers before surgery. In practice the decolonization procedures are not well-defined according notably to the duration and time of delivery before surgery and doses of topical antimicrobial drugs. The aim of the proposed study is to investigate the factors associated with failures of S. aureus decolonization: carriage state, compliance with treatment, S. aureus capacity of internalization in nasal epithelial cells, resistance to antimicrobial drugs used. This study will allow (i) to measure the frequency of patients with residual S. aureus carriage just before surgery, whatever they have been decolonized or not, (ii) to characterize the S. aureus nasal carriage state of patients before surgery, and (iii) to investigate the adding value of mupirocin dosage in the nose and urines of decolonized patients as a marker of compliance and efficacy of the decolonization process.

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

  • Patient to benefit from cardiac surgery scheduled at Saint-Etienne University Hospital
  • Surgery of first intention (no resumption)
  • Patient affiliated or entitled to a social security scheme
  • Patient agreeing to participate in the study and having signed the informed consent

排除标准

  • Surgery in a context of infection
  • Surgery in an emergency and semi-emergency context
  • Protected major patient

结局指标

主要结局

number of participants with failure of decolonization of nasal carriers of S. aureus

时间窗: just before surgery

These patients were screened positive for S. aureus in nasal swab culture collected during the preoperative consultation of cardiac surgery, who received a decolonization prescription and who are again detected positive in culture for S. aureus on the nasal collection performed on admission to the surgery department (just before surgery).

次要结局

  • Prevalence of nasal carriage of S. aureus 3 months after cardiac surgery in all patients(3 months)
  • Correlation between nasal dosing of mupirocin and compliance(3 months)
  • Prevalence of nasal carriage of S. aureus just prior to cardiac surgery in all patients(before surgery)
  • Correlation between mupirocin urine metabolite assay associated with mupirocin nasal dosing and decolonization efficacy (failure or not).(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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