Prodromes of Menstrual Staphylococcal Toxic Shock

Recruiting

• Conditions: Toxic Shock Syndrome Staphylococcal
• Interventions: Other: Identification of symptoms of menstrual in control patient in the last three menstrual period; Other: Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period

• Registration Number: NCT06124599
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-21
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-12-21
• Study Completion: 2026-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 316

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control healthy women	Identification of symptoms of menstrual in control patient in the last three menstrual period	Women over 13 years of age, menstruating and using internal sanitary protection with No history of menstrual toxic shock for controls
Women who have developed menstrual staphylococcal toxic shock	Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period	Clinical diagnosis of staphylococcal toxic shock syndrome: "confirmed" or "probable" according to CDC criteria : The 5 CDC clinical criteria for Staphylococcal Toxic Shock are: * a fever above 39°C, * arterial hypotension, * generalized scarlatiniform erythroderma * intense desquamation of the palms or soles of the feet 7 to 14 days later, * and systemic manifestations (at least three): * Digestive: vomiting, diarrhea * Muscular: myalgias, increased serum creatine phospho-kinase * Vaginal, oropharyngeal and conjunctival mucosal hyperemia * Renal: hyperuricemia, hypercreatininemia, leukocyturia without urinary infection, * Hepatic: increased transaminases * Hematological: thrombocytopenia (\< 100,000 platelets/mm3) * Neurological: excluding episodes of fever or hypotension such as disorientation or altered consciousness. If 4 criteria are met, the case is considered probable, and if 5 criteria are met, confirmed.

Primary Outcome Measures

Name	Time	Method
Women with No history of menstrual toxic shock for controls	in the week following the last menstrual period	A single collection of information through a questionnaire delivered to the last menstrual period
Patient with Menstrual Staphylococcal Toxic Shock (STC)	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

Trial Locations

Locations (1)

Hopital Nord Croix Rousse; 🇫🇷 Lyon, France