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临床试验/NCT02026895
NCT02026895已完成不适用

Virulence of Staphylococcus Lugdunensis in Severe Infections

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2013年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
2
主要终点
Presence/absence of virulence factors

研究概览

简要总结

The main objective is to identify new virulence factors produced by Staphylococcus lugdunensis that can be associated with clinical sign of severe infections and identified symptoms. The methodological approach is based on the comparison between the production of toxins by a given S. lugdunensis isolate classified in patients groups according to the infection clinically defined. Each group will be compared to the presence or not of studied virulence factors. Clinical features associated with toxin activity are not known for S. lugdunensis. This comparative approach is based on the hypotheses that drove to the definition of patient groups and their clinical criteria. However, in the absence of the evident correlation between production of toxins and kind of infection, the statistical evaluation will be completed by a multi-varied analysis. This approach has not been choosen first because of the multiple parameters that undergo during infection that may reveal relationships without true correlation. About the number of included patients in each defined group, if one of them does not reach the expected count, we still might extend inclusions to 3-6 months more. The presence of severe infections without usually defined risk is intriguing. For these last patients, we have planned, after their individual consent to achieve an exome sequencing. The obtained data will be compared to available resources for the human genome. By filtering data through usual protocols, we hope to able to focus onto few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to S. lugdunensis without defined risk.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • Age 18 or more
  • Signed informed consent form
  • Proved infection by Staphylococcus lugdunensis: bacteremia, urine tract infection, endocarditis, bone and joint infections, skin and soft tissue infection, deep infection.

排除标准

  • Age under 18
  • Pregnancy or breastfeeding
  • Contamination by Staphylococcus lugdunensis

结局指标

主要结局

Presence/absence of virulence factors

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Several groups will be compared considering the presence/absence of virulence factors: Bacteriemic VS non bacteriemic, Deep infection VS Skin/mucosal infection, Foreign body infection VS not, Presence of abscess VS not, Sepsis VS no sepsis, Septic embolism VS not, Portal of entry or not The following virulence factors will be searched for: TSST-1, enterotoxins, leukotoxins, epidermolysins, beta-hemolysins, SCIN-CHIPS, Sbi, Efb, SdrE

次要结局

  • Clinical characteristics of infections(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
  • Whole human transcriptome analysis for selected patients(Genetic blood samples will be analyzed together after the end of inclusion period (18 months))
  • Genome sequencing of selected strains of Staphylococcus lugdunensis(Genetic blood samples will be analyzed together after the end of inclusion period (18 months))

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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