Phase
Condition
Low Blood Pressure (Hypotension)
Treatment
Identification of symptoms of menstrual in control patient in the last three menstrual period
Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period
Clinical Study ID
Ages 13-30 Female Accepts Healthy Volunteers
Study Summary
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 urinaryinfection,
Hepatic: increase in transaminases
Hematological: thrombocytopenia (< 100,000 platelets/mm3)
Neurological: apart from episodes of fever or hypotension such asdisorientation 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) onvaginal samples.
Onset of symptoms ≤ 72 hours before the start of menstruation and ≥ 72 hours afterthe 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 3periods
No history of toxic menstrual shock
Exclusion
Exclusion Criteria:
Non-menstruating women
Women protected by law
Women (or relatives) who oppose the study
Study Design
Connect with a study center
Hopital Nord Croix Rousse
Lyon, 69004
FranceActive - Recruiting
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