Understanding early symptoms of menstrual staphylococcal toxic shock
Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock
This study is trying to find out the early warning signs of menstrual staphylococcal toxic shock syndrome in young women aged 13 to 30 to help with quicker diagnosis and understanding of this serious condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 316 (estimated) |
| Ages | 13 Years to 30 Years |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06124599 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the prodromal symptoms of menstrual staphylococcal toxic shock syndrome in young women. It focuses on women aged 13 to 30 who have been diagnosed with this rare condition, as well as control patients. By analyzing symptoms reported during the last three menstrual periods, the study seeks to improve early diagnosis and understanding of this severe illness. The research is conducted at the Hopital Nord Croix Rousse in Lyon.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 13 to 30 who have been clinically diagnosed with staphylococcal toxic shock syndrome.
Not a fit: Patients who do not meet the age criteria or have not been diagnosed with staphylococcal toxic shock syndrome will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of menstrual staphylococcal toxic shock syndrome, potentially reducing morbidity and mortality.
How similar studies have performed: While menstrual staphylococcal toxic shock is rare, similar studies on prodromal symptoms in other conditions have shown promise in improving early diagnosis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lyon
- Hopital Nord Croix Rousse — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Gerard LINA, MD
- Email: gerard.lina@chu-lyon.fr
- Phone: 04 72 07 16 94
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.