AnaphylaxisNCT03953482
Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis
An observational study of Anaphylaxis, run by Fondation Hôpital Saint-Joseph at 2 sites in France.
Trial summary
Anaphylaxis is a hypersensitivity reaction systemic, generalized, severe, life-threatening that may result from exposure to a triggering factor. The prevalence of anaphylaxis is 0.05 to 2% in the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaphylaxis
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Oct 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a history of an anaphylactic reaction
Who may be able to join
- Patient whose age ≥ 18 years
- Francophone patient
- Patient not opposing his participation in the research protocol
- Patient with a history of an anaphylactic reaction
Who cannot join
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient presenting an allergic reaction or an anaphylaxis
- For patients presenting to emergencies at Groupe Hospitalier Paris Saint-Joseph (GHPSJ) : Unstable health estate (gravity criteria hemodynamic, respiratory or neurological and any pathologies with a severity that do not allow the questionnaire to be answered).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maison de santé porte de Vanves
Paris, 75014
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Anaphylaxis is a hypersensitivity reaction systemic, generalized, severe, life-threatening that may result from exposure to a triggering factor. The prevalence of anaphylaxis is 0.05 to 2% in the general population. Most reactions appear within 30 minutes after contact with the triggering factor and last up to 6 hours. The main triggering factors are: 1/food, 2/hymenopteran bites, 3/drugs. The main treatment is the early administration of adrenaline by Intramuscular route on medical prescription or by AAI (adrenaline auto-injector) associated with the exclusion of the allergen. Adrenaline treatment should be administered as soon as possible, a failure or delay in the use of adrenaline is a risk factor for death. Anaphylaxis is a chronic disease and the patient must be informed from the first episode about the risk of recurrence and the risk of death he is exposed to. Patient education is essential for the complete removal of the triggering factor, recognition of anaphylaxis symptoms and use of AAI. The risk of recurrence is high given the difficulty to completely eliminate the favourable factor (mainly food causes and hymenopteran bites): 1/3 of deaths from food anaphylaxis occur at home, and the peak mortality rate is between 10 and 30 years old. The diagnosis of anaphylaxis can be difficult because the symptomatology can be so varied. It is under-diagnosed, which leads to a lack of medical care and therefore an under-prescription of AAI. Some American studies identifying emergency room visits for anaphylaxis find that in less than 30% of cases there is a prescription for AAI, in less than 40% of advices about triggering factor's eviction and in less than 20% a guidance to an allergology consultation. In France, the HAS published in 2013 a procedure to be followed after the treatment of a suspected anaphylaxis: the patient's management must be diagnostic, therapeutic and educational. It must be systematically based on three axes:
- the prescription of AAI with an explanation of its use,
- the provision of written information on the mechanism and symptoms of anaphylaxis, attitude to be followed in event of an anaphylactic reaction, and need for eviction if the allergen has been identified,
- guidance to an allergology consultation.
Therapeutic education for anaphylactic patients is essential given the risk involved. In an American study, it was shown that only 60% of teens and young adults suffering from food allergies report having AAI systematically with them. Information and education is therefore essential for these patients.
- Conditions
- Anaphylaxis
- Medical subject headings
- Anaphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's medical management after a first episode of anaphylaxis
Percentage of patients who had management with:
- an adrenaline auto-injector prescription (yes/no)
- an eviction advice distribution (yes/no),
- an allergology consultation (yes/no).
Measured: Day 0
Secondary outcomes (1)
Patient's knowledge of attitude to have with anaphylaxis
Percentage of correct answers to the study-specific questionnaire related to knowledge of attitude to have with a new anaphylactic reaction.
Measured: Day0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start16 Oct 2018
- Primary completion16 Aug 2019
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eloïse P TRABATTONI, MD, Study director, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953482
- Sponsor's protocol ID
- PREVANA
- Status last verified
- Apr 2023
- First submitted
- 15 May 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis
- ClinicalTrials.gov ID
- NCT03953482
- Acronym / sponsor ID
- PREVANA
- Conditions
- Anaphylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 May 2019 (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.
Anaphylaxis is a hypersensitivity reaction systemic, generalized, severe, life-threatening that may result from exposure to a triggering factor. The prevalence of anaphylaxis is 0.05 to 2% in the general population. Most reactions appear within 30 minutes after contact with the triggering factor and last up to 6 hours. The main triggering factors are: 1/food, 2/hymenopteran bites, 3/drugs. The main treatment is the early administration of adrenaline by Intramuscular route on medical prescription or by AAI (adrenaline auto-injector) associated with the exclusion of the allergen. Adrenaline treatment should be administered as soon as possible, a failure or delay in the use of adrenaline is a risk factor for death. Anaphylaxis is a chronic disease and the patient must be informed from the first episode about the risk of recurrence and the risk of death he is exposed to. Patient education is essential for the complete removal of the triggering factor, recognition of anaphylaxis symptoms and use of AAI. The risk of recurrence is high given the difficulty to completely eliminate the favourable factor (mainly food causes and hymenopteran bites): 1/3 of deaths from food anaphylaxis occur at home, and the peak mortality rate is between 10 and 30 years old. The diagnosis of anaphylaxis can be difficult because the symptomatology can be so varied. It is under-diagnosed, which leads to a lack of medical care and therefore an under-prescription of AAI. Some American studies identifying emergency room visits for anaphylaxis find that in less than 30% of cases there is a prescription for AAI, in less than 40% of advices about triggering factor's eviction and in less than 20% a guidance to an allergology consultation. In France, the HAS published in 2013 a procedure to be followed after the treatment of a suspected anaphylaxis: the patient's management must be diagnostic, therapeutic and educational. It must be systematically based on three axes:
- the prescription of AAI with an explanation of its use,
- the provision of written information on the mechanism and symptoms of anaphylaxis, attitude to be followed in event of an anaphylactic reaction, and need for eviction if the allergen has been identified,
- guidance to an allergology consultation.
Therapeutic education for anaphylactic patients is essential given the risk involved. In an American study, it was shown that only 60% of teens and young adults suffering from food allergies report having AAI systematically with them. Information and education is therefore essential for these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a history of an anaphylactic reaction
Key inclusion criteria (4 listed)
- Patient whose age ≥ 18 years
- Francophone patient
- Patient not opposing his participation in the research protocol
- Patient with a history of an anaphylactic reaction
Key exclusion criteria (4 listed)
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient presenting an allergic reaction or an anaphylaxis
- For patients presenting to emergencies at Groupe Hospitalier Paris Saint-Joseph (GHPSJ) : Unstable health estate (gravity criteria hemodynamic, respiratory or neurological and any pathologies with a severity that do not allow the questionnaire to be answered).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient's medical management after a first episode of anaphylaxis
Time frame: Day 0
Percentage of patients who had management with: * an adrenaline auto-injector prescription (yes/no) * an eviction advice distribution (yes/no), * an allergology consultation (yes/no).
1 secondary outcome
Patient's knowledge of attitude to have with anaphylaxis
Time frame: Day0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Eloïse P TRABATTONI, MD study director
Fondation Hôpital Saint-Joseph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis, run by Fondation Hôpital Saint-Joseph at 2 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's medical management after a first episode of anaphylaxis (time frame: Day 0). 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 27 Apr 2023.