Clinical trial NCT06124599: Prodromes of Menstrual Staphylococcal Toxic Shock
Official title: Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Toxic Shock Syndrome Staphylococcal
Keywords: Menstrual toxic shock
Staphylococcus aureus
prodromes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 316
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who develop menstrual toxic shock will be identified by reporting their disease to the national staphylococcal reference center by their physician

Brief summary: 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.


Eligibility criteria: 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 intimate periodic protection, tampon or menstrual cup, during the last 3 periods
* No history of toxic menstrual shock

Exclusion Criteria:

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

Primary outcomes:
measure: Women with No history of menstrual toxic shock for controls
timeFrame: in the week following the last menstrual period
measure: Patient with Menstrual Staphylococcal Toxic Shock (STC)
timeFrame: in the week following onset Staphylococcal Toxic Shock
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Nord Croix Rousse
Study officials:
References: