Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||N/A and Over|
- - Allergy to hymenoptera venom.
- - Treated with VIT at the university hospital of Angers.
- - Ceased VIT between 2005 and 2019.
- - Patient's opposition, or the Participant's legal guardian's, if minor, to participate to the study, and/or for his data to be used.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital, Angers|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Anaphylaxis Caused by Hymenoptera Venom (Disorder)|
Allergy to Hymenoptera venom is one of the main causes of anaphylaxis in adults, and is less common in the paediatric population. It can be severe or even fatal. Despite the use of an emergency kit, including an adrenaline auto-injector (AAI), at present only hymenoptera venom immunotherapy (VIT) is effective in preventing subsequent severe systemic reactions. Recurrence during the 5 years following cessation of VIT is about 10-15 percent. Studies evaluating longer-term efficacy are scarce. At the University Hospital of Angers, hundreds of patients are treated each year, and its allergology unit has been providing VIT for over 15 years. The purpose of this stufy is to evaluate VIT efficacy among patients who were treated with VIT and ceased VIT from 2005 to 2019, at the university hospital of Angers. This is a monocentric and ambispective study. In the absence of opposition from the patient (within one month after the information letter was sent), the search for data of interest is carried out by consulting the participant's medical record. An investigator (doctor or intern) interviews the participant, or the legal guardian for minors, and performs a telephone survey. Data are collected from the participants medical records. Information gathered are as follows : age, sexe, the date and symptoms following hyménoptera stings, the evolution of allergy skin testing, total and venom specific immunoglobuin E (IgE), venom specifc immunoglobulin G4 (IgG4), basophil activation tests (BAT) to hymenoptera venom, exposure to hymenoptera stings. The telephone survey assesses potential new comorbidities and new treatments, exposure to hymeoptera stings, hymenoptera stings after VIT cessation, if known : the hymenoptera specy, the participants reaction to the sting, and the drug that has been used to treat the symptoms.
All participants that cesed VIT between 2005 and 2019, and did not withdraw his consent to participate to the study.
Other: - Telephone survey
All participants are interviewed by telephone, and are asked to answer a survey.
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.