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.
Who can participate
Age range
13 Years – 30 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria :
+Case inclusion criteria:
* Women between 13 and 30 years old inclusive
* Clinical diagnosis of staphylococcal toxic shock syndrome: "confirmed" or "probable" according to Center Disease Control (CDC) criteria:
The 5 CDC clinical criteria for menstrual Staphylococcal Toxic Shock are:
* a fever above 39°C,
* arterial hypotension,
* generalized scarlatiniform erythroderma
* intense peeling of the palms or soles of the feet 7 to 14 days later,
* and systemic manifestations (at least three):
* Digestive: vomiting, diarrhea
* Muscular: myalgia, increase in serum creatine phosphokinase
* Hyperemia of the vaginal, oropharyngeal and conjunctival mucous membranes
* Renal: hyperuricemia, hypercreatininemia, leukocyturia without urinary infection,
* Hepatic: increase in transaminases
* Hematological: thrombocytopenia (\< 100,000 platelets/mm3)
* Neurological: apart from episodes of fever or hypotension such as disorientation or altered consciousness.
In the presence of 4 criteria, the case is considered probable and 5 criteria as confirmed case.
* Detection of S. aureus strain carrying Toxic shock syndrome toxin-1 (TSST1) on vaginal samples.
* Onset of symptoms ≤ 72 hours before the start of menstruation and ≥ 72 hours after the end of menstruation.
* Use during the last 3 cycles of vaginal protection: tampon or menstrual cup.
+Control inclusion criteria:
* Women between 13 and 30 years old inclusive
* Presence of menstruation
* Use of intima…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Women with No history of menstrual toxic shock for controls
Timeframe: in the week following the last menstrual period
2
Patient with Menstrual Staphylococcal Toxic Shock (STC)
Timeframe: in the week following onset Staphylococcal Toxic Shock