Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis
Study Purpose
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.
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03953482 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
|
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Fondation Hôpital Saint-Joseph |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Eloïse P TRABATTONI, MD |
| Principal Investigator Affiliation | Fondation Hôpital Saint-Joseph |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Active, not recruiting |
| Countries | France |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Anaphylaxis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
