Hopital Nord Croix Rousse
Lyon, 69004, France
Location status: Recruiting
NCT Number: NCT06124599
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.
Interested in participating?
Request Info13 year–30 year
Female
Observational
Lyon, 69004, France
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
+Case inclusion criteria:
The 5 CDC clinical criteria for menstrual Staphylococcal Toxic Shock are:
In the presence of 4 criteria, the case is considered probable and 5 criteria as confirmed case.
+Control inclusion criteria:
Exclusion criteria
questionnaire including : fever felt or measured; chills; malaise or feeling of malaise (dizziness when standing up); unusual fatigue; headache; confusion, disorientation; nausea; vomiting; diarrhea; abdominal pain; muscle pain, aches; sore throat or pain when swallowing; red tongue or mouth ulceration; skin rashes (redness, patches...); other
questionnaire including : fever felt or measured; chills; malaise or feeling of malaise (dizziness when standing up); unusual fatigue; headache; confusion, disorientation; nausea; vomiting; diarrhea; abdominal pain; muscle pain, aches; sore throat or pain when swallowing; red tongue or mouth ulceration; skin rashes (redness, patches...); other...
Time frame: in the week following the last menstrual period
A single collection of information through a questionnaire delivered to the last menstrual period
Time frame: 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
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock
Acronym: IPro-CTSm
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