Toxic Shock Syndrome StaphylococcalIPro-CTSmNCT06124599
Prodromes of Menstrual Staphylococcal Toxic Shock
An observational study of Toxic Shock Syndrome Staphylococcal, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 13 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Toxic Shock Syndrome Staphylococcal
- What is being tested?
- Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period
- How many people
- 316 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2021to 21 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Patients who develop menstrual toxic shock will be identified by reporting their disease to the national staphylococcal reference center by their physician
Who may be able to join
- +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,
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- 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
Who cannot join
- Non-menstruating women
- Women protected by law
- Women (or relatives) who oppose the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Nord Croix Rousse
Lyon, 69004
Gerard LINA, MD, 04.72.07.16.94 ext. +33, gerard.lina@chu-lyon.fr
About this study
Official title: Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock
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.
Read more
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
- Being tested
- Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual period, Identification of symptoms of menstrual in control patient in the last three menstrual period
- Keywords
- Menstrual toxic shock, Staphylococcus aureus, prodromes
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual periodOther
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 periodOther
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...
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Identification of symptoms of menstrual in control patient in the last three menstrual period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women with No history of menstrual toxic shock for controls
A single collection of information through a questionnaire delivered to the last menstrual period
Measured: 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
Measured: in the week following onset Staphylococcal Toxic Shock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start21 Dec 2021
- Primary completion21 Dec 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxic Shock Syndrome StaphylococcalStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124599
- Sponsor's protocol ID
- 69HCL20_1008
- Acronym
- IPro-CTSm
- Status last verified
- Dec 2024
- First submitted
- 26 Oct 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prodromal Clinical Signs of Menstrual Staphylococcal Toxic Shock
- ClinicalTrials.gov ID
- NCT06124599
- Acronym / sponsor ID
- IPro-CTSm / 69HCL20_1008
- Conditions
- Toxic Shock Syndrome Staphylococcal
- Keywords
- Menstrual toxic shock, Staphylococcus aureus, prodromes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women who have developed menstrual staphylococcal toxic shock | – | Other: Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual periodClinical 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. |
| Control healthy women | – | Other: Identification of symptoms of menstrual in control patient in the last three menstrual periodWomen over 13 years of age, menstruating and using internal sanitary protection with No history of menstrual toxic shock for controls |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients who develop menstrual toxic shock will be identified by reporting their disease to the national staphylococcal reference center by their physician
Key inclusion criteria (25 listed)
- 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:
- a fever above 39°C,
- arterial hypotension,
- generalized scarlatiniform erythroderma
Key exclusion criteria (3 listed)
- Non-menstruating women
- Women protected by law
- Women (or relatives) who oppose the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of symptoms of menstrual staphylococcal toxic shock in last three menstrual periodquestionnaire 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 | Other | Women who have developed menstrual staphylococcal toxic shock |
| Identification of symptoms of menstrual in control patient in the last three menstrual periodquestionnaire 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... | Other | Control healthy women |
Primary outcome
Women with No history of menstrual toxic shock for controls
Time frame: in the week following the last menstrual period
A single collection of information through a questionnaire delivered to the last menstrual period
Patient with Menstrual Staphylococcal Toxic Shock (STC)
Time frame: in the week following onset Staphylococcal Toxic Shock
A single collection of information through a questionnaire delivered as close as possible to the occurrence of the STC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxic Shock Syndrome Staphylococcal, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerard LINA, MD (04 72 07 16 94 ext. +33, gerard.lina@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women with No history of menstrual toxic shock for controls (time frame: in the week following the last menstrual period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.