Prodromes of Menstrual Staphylococcal Toxic Shock

Last updated: December 5, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

Identification of symptoms of menstrual in control patient in the last three menstrual period

Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period

Clinical Study ID

NCT06124599
69HCL20_1008
  • Ages 13-30
  • Female
  • Accepts Healthy Volunteers

Study 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

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 urinaryinfection,

  • Hepatic: increase in transaminases

  • Hematological: thrombocytopenia (< 100,000 platelets/mm3)

  • Neurological: apart from episodes of fever or hypotension such asdisorientation 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) onvaginal samples.

  • Onset of symptoms ≤ 72 hours before the start of menstruation and ≥ 72 hours afterthe 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 3periods

  • No history of toxic menstrual shock

Exclusion

Exclusion Criteria:

  • Non-menstruating women

  • Women protected by law

  • Women (or relatives) who oppose the study

Study Design

Total Participants: 316
Treatment Group(s): 2
Primary Treatment: Identification of symptoms of menstrual in control patient in the last three menstrual period
Phase:
Study Start date:
December 21, 2021
Estimated Completion Date:
December 21, 2026

Connect with a study center

  • Hopital Nord Croix Rousse

    Lyon, 69004
    France

    Active - Recruiting

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