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NCT06124599: IPro-CTSm

Prodromes of Menstrual Staphylococcal Toxic Shock

Recruiting now Last updated 6 December 2024
What this trial tests

trial testing Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period in Toxic Shock Syndrome Staphylococcal in 316 participants. Currently enrolling.

Timeline
21 December 2021
Primary endpoint
21 December 2026
21 December 2026

Quick facts

Lead sponsorHospices Civils de Lyon
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment316
Start date21 December 2021
Primary completion21 December 2026
Estimated completion21 December 2026
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 13 to 30, female only, with Toxic Shock Syndrome Staphylococcal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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Data sources for this page

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