Clinical trial NCT05311644: Hymenoptera Venom Immunotherapy: Evaluation of Its Long-term Efficacy at the University Hospital of Angers (EFLOTITA2)
Official title: La désensibilisation Aux Venins d'hyménoptères : Quelle Est Son efficacité à Long Terme ? (EFLOTITA2)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anaphylaxis Caused by Hymenoptera Venom (Disorder)
Keywords: hymenoptera venom immunotherapy; anaphylaxis; venom allergy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-04-05
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Allergy to hymenoptera venom, Treated with VIT at the university hospital of Angers, Ceased VIT between 2005 and 2019

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Allergy to hymenoptera venom.
* Treated with VIT at the university hospital of Angers.
* Ceased VIT between 2005 and 2019.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reccurence of a systemic reaction
timeFrame: up to 17 years since the patient ceased hymenoptera venom immunotherapy.
Secondary outcomes:
measure: To describe the evolution of the results of the allergy work-up during hymenoptera venom immunotherapy
timeFrame: up to 17 years since the patient ceased hymenoptera venom immunotherapy to the last appointement in the allergy unit.
measure: Predicting the recurrence of systemic symptoms
timeFrame: up to 17 years since the patient ceased hymenoptera venom immunotherapy until the phone survey
Other outcomes:
Locations:
city: Angers
country: France
facility: University hospital of Angers
state: Maine Et Loire
Study officials:
References: