Status:
RECRUITING
Prodromes of Menstrual Staphylococcal Toxic Shock
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Toxic Shock Syndrome Staphylococcal
Eligibility:
FEMALE
13-30 years
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 hea...
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 urinary infection,
- Hepatic: increase in transaminases
- Hematological: thrombocytopenia (\< 100,000 platelets/mm3)
- Neurological: apart from episodes of fever or hypotension such as disorientation 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) on vaginal samples.
- Onset of symptoms ≤ 72 hours before the start of menstruation and ≥ 72 hours after the 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 3 periods
- No history of toxic menstrual shock
- Exclusion Criteria:
- Non-menstruating women
- Women protected by law
- Women (or relatives) who oppose the study
Exclusion
Key Trial Info
Start Date :
December 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 21 2026
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT06124599
Start Date
December 21 2021
End Date
December 21 2026
Last Update
December 6 2024
Active Locations (1)
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1
Hopital Nord Croix Rousse
Lyon, France, 69004