Prodromes of Menstrual Staphylococcal Toxic Shock

NCT ID: NCT06124599

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 316 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2026-12-21

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 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.

Conditions

Toxic Shock Syndrome Staphylococcal

Keywords

Menstrual toxic shock; Staphylococcus aureus; prodromes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Women who have developed menstrual staphylococcal toxic shock

Clinical diagnosis of staphylococcal toxic shock syndrome: "confirmed" or "probable" according to CDC criteria :

The 5 CDC clinical criteria for Staphylococcal Toxic Shock are:

• a fever above 39°C,
• arterial hypotension,
• generalized scarlatiniform erythroderma
• intense desquamation of the palms or soles of the feet 7 to 14 days later,
• and systemic manifestations (at least three):

• Digestive: vomiting, diarrhea
• Muscular: myalgias, increased serum creatine phospho-kinase
• Vaginal, oropharyngeal and conjunctival mucosal hyperemia
• Renal: hyperuricemia, hypercreatininemia, leukocyturia without urinary infection,
• Hepatic: increased transaminases
• Hematological: thrombocytopenia (< 100,000 platelets/mm3)
• Neurological: excluding episodes of fever or hypotension such as disorientation or altered consciousness.

If 4 criteria are met, the case is considered probable, and if 5 criteria are met, confirmed.

Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period

Intervention Type: OTHER

questionnaire including : fever felt or measured; chills; malaise or feeling of malaise (dizziness when standing up); unusual fatigue; headache; confusion, disorientation; nausea; vomiting; diarrhea; abdominal pain; muscle pain, aches; sore throat or pain when swallowing; red tongue or mouth ulceration; skin rashes (redness, patches...); other

Control healthy women

Women over 13 years of age, menstruating and using internal sanitary protection with No history of menstrual toxic shock for controls

Identification of symptoms of menstrual in control patient in the last three menstrual period

Intervention Type: OTHER

questionnaire including : fever felt or measured; chills; malaise or feeling of malaise (dizziness when standing up); unusual fatigue; headache; confusion, disorientation; nausea; vomiting; diarrhea; abdominal pain; muscle pain, aches; sore throat or pain when swallowing; red tongue or mouth ulceration; skin rashes (redness, patches...); other...

Interventions

Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period

questionnaire including : fever felt or measured; chills; malaise or feeling of malaise (dizziness when standing up); unusual fatigue; headache; confusion, disorientation; nausea; vomiting; diarrhea; abdominal pain; muscle pain, aches; sore throat or pain when swallowing; red tongue or mouth ulceration; skin rashes (redness, patches...); other

Intervention Type: OTHER

Identification of symptoms of menstrual in control patient in the last three menstrual period

questionnaire including : fever felt or measured; chills; malaise or feeling of malaise (dizziness when standing up); unusual fatigue; headache; confusion, disorientation; nausea; vomiting; diarrhea; abdominal pain; muscle pain, aches; sore throat or pain when swallowing; red tongue or mouth ulceration; skin rashes (redness, patches...); other...

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Nord Croix Rousse

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Gerard LINA, MD

Role: CONTACT

Phone: 04 72 07 16 94

Email: gerard.lina@chu-lyon.fr

Facility Contacts

Gerard LINA, MD

Role: primary

Other Identifiers

69HCL20_1008

Identifier Type: -

Identifier Source: org_study_id