Prodromes of Menstrual Staphylococcal Toxic Shock

NCT06124599 | Recruiting

• 1 other identifier: 69HCL20_1008
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Women with No history of menstrual toxic shock for controls

  A single collection of information through a questionnaire delivered to the last menstrual period

  in the week following the last menstrual period

• Patient with Menstrual Staphylococcal Toxic Shock (STC)

  A single collection of information through a questionnaire delivered as close as possible to the occurrence of the STC

  in the week following onset Staphylococcal Toxic Shock

Study Arms (2)

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.

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

Control healthy women

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

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

Interventions

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

Women who have developed menstrual staphylococcal toxic shock

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

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who develop menstrual toxic shock will be identified by reporting their disease to the national staphylococcal reference center by their physician

You may qualify if:

• 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.

You may not qualify if:

• Non-menstruating women
• Women protected by law
• Women (or relatives) who oppose the study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Nord Croix Rousse

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Gerard LINA, MD

CONTACT

04 72 07 16 94; gerard.lina@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 9, 2023
• Study Start: December 21, 2021
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

FR (1)