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NCT06124599: IPro-CTSm
Prodromes of Menstrual Staphylococcal Toxic Shock
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.
21 December 2026
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 316 |
| Start date | 21 December 2021 |
| Primary completion | 21 December 2026 |
| Estimated completion | 21 December 2026 |
| Sites | 1 location across France |
Drugs / interventions tested
- Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period
- Identification of symptoms of menstrual in control patient in the last three menstrual period
Conditions studied
- Toxic Shock Syndrome Staphylococcal — all drugs for Toxic Shock Syndrome Staphylococcal →
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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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06124599 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 6 December 2024
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