Prodromes of Menstrual Staphylococcal Toxic Shock

Toxic Shock Syndrome Staphylococcal Clinical Trial

— IPro-CTSm  

Official title:

Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124599
• Other study ID #: 69HCL20_1008
• Status: Recruiting
• Start date: December 21, 2021
• Est. completion date: December 21, 2026

Study information

• Verified date: November 2023
• Source: Hospices Civils de Lyon
• Contact: Gerard LINA, MD
• Phone: 04 72 07 16 94
• Email: gerard.lina[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: December 21, 2026
• Est. primary completion date: December 21, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Shock
• Shock, Septic
• Toxic Shock Syndrome Staphylococcal

Intervention

Other:
• 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
• 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...

Locations

Country	Name	City	State
France	Hopital Nord Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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