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Status unknownNCT03953482Updated Apr 27, 2023

Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis

An observational study in Anaphylaxis, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Anaphylaxis

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03

In context

Anaphylaxis

100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.

This study's enrollment of 66 is below the median of 137 across 48 observational studies indexed under Anaphylaxis.

Browse Anaphylaxis studies →

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with a history of an anaphylactic reaction

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient whose age ≥ 18 years
  • Francophone patient
  • Patient not opposing his participation in the research protocol
  • Patient with a history of an anaphylactic reaction

Exclusion criteria

Exclusion Criteria:

  • 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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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.

    Time frame: Day0

07

Study locations

2 sites
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile-de-France 75014, France
  • Maison de santé porte de Vanves
    Paris, 75014, France
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2018 to primary completion in Aug 2019, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2019
First posted
May 16, 2019
StartActual
Oct 16, 2018
Primary completionActual
Aug 16, 2019
CompletionEst.
Dec 31, 2023
Last update
Apr 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03953482
Responsible party
Sponsor
First posted
May 16, 2019
Start date
Oct 16, 2018
Primary completion
Aug 16, 2019
Completion
Dec 31, 2023 (estimated)
Last update
Apr 27, 2023

Study contacts

Eloïse P TRABATTONI, MD
study director · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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