Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124599
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-10-26
Brief Title:
Prodromes of Menstrual Staphylococcal Toxic Shock
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPro-CTSm
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 ie 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None