Prodromes of Menstrual Staphylococcal Toxic Shock

Launched by HOSPICES CIVILS DE LYON · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a serious condition called menstrual staphylococcal toxic shock syndrome, which can occur in young women during their menstrual periods. The goal is to identify early warning signs—known as prodromal symptoms—that might appear in the days leading up to the onset of toxic shock. By recognizing these symptoms, women can remove their tampons or menstrual cups, which are the main risk factors, before the condition becomes severe and requires intensive medical care.

Women aged 13 to 30 who have experienced toxic shock syndrome or are at risk may be eligible to participate in this study. To qualify, participants need to have specific symptoms and be confirmed or suspected to have toxic shock syndrome based on established clinical criteria. Those who join the study can expect to provide vaginal samples and share their experiences related to their menstrual cycles. The findings from this trial could help improve early detection and treatment for this rare but dangerous condition.

Gender

FEMALE

Eligibility criteria

• 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