Prodromes of Menstrual Staphylococcal Toxic Shock

NCT06124599 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 316

Last updated 2024-12-06

No results posted yet for this 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.

Conditions

  • Toxic Shock Syndrome Staphylococcal

Interventions

OTHER

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

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

OTHER

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

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...

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
13 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2026-12-21
Completion
2026-12-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124599 on ClinicalTrials.gov