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临床试验/NCT06124599
NCT06124599招募中不适用

Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2021年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
316
试验地点
1
主要终点
Women with No history of menstrual toxic shock for controls

研究概览

简要总结

Menstrual staphylococcal toxic shock is a rare but severe disease, requiring intensive care in over 80% of cases. Menstrual staphylococcal toxic shock develops during the peri-menstrual period, in healthy young women colonized by a vaginal strain of Staphylococcus aureus secreting the Toxic shock syndrome toxin 1 (TSST-1) and not immune to it, in a favorable environment, i.e. wearing intravaginal menstrual protection (tampon, menstrual cup).

The rarity of the syndrome, its polymorphous clinical presentation and the absence of a totally specific biological examination make menstrual staphylococcal toxic shock a difficult pathology to diagnose. The reference clinical criteria correspond to the advanced picture of multivisceral failure, making it possible to classify cases a posteriori, but contribute to diagnostic delay and lack sensitivity.

Patient accounts suggest the presence of symptoms in the days preceding the development of toxic shock, and also during previous menstrual cycles.

The identification of prodromal symptoms could enable earlier management of menstrual staphylococcal toxic shock by removal of intra-vaginal sanitary protection, the main risk factor, before the disease becomes permanently established and requires intensive care.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
13 Years 至 30 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Non-menstruating women
  • Women protected by law
  • Women (or relatives) who oppose the study

结局指标

主要结局

Women with No history of menstrual toxic shock for controls

时间窗: in the week following the last menstrual period

A single collection of information through a questionnaire delivered to the last menstrual period

Patient with Menstrual Staphylococcal Toxic Shock (STC)

时间窗: in the week following onset Staphylococcal Toxic Shock

A single collection of information through a questionnaire delivered as close as possible to the occurrence of the STC

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Prodromes of Menstrual Staphylococcal Toxic Shock | 临床试验