Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock
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
- 是
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
