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Completed

NCT Number: NCT05311644

Hymenoptera Venom Immunotherapy: Evaluation of Its Long-term Efficacy at the University Hospital of Angers (EFLOTITA2)

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Angers

Angers, Maine et Loire, 49100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone survey

Other

All participants are interviewed by telephone, and are asked to answer a survey.

Primary outcomes

  1. Reccurence of a systemic reaction

    Time frame: up to 17 years since the patient ceased hymenoptera venom immunotherapy.

    The recurrence of a systemic reaction after a hymenoptera sting reported by the patient during the telephone survey.

Secondary outcomes

  1. To describe the evolution of the results of the allergy work-up during hymenoptera venom immunotherapy

    Time frame: up to 17 years since the patient ceased hymenoptera venom immunotherapy to the last appointement in the allergy unit.

    Results of skin-testing and blood work

  2. Predicting the recurrence of systemic symptoms

    Time frame: up to 17 years since the patient ceased hymenoptera venom immunotherapy until the phone survey

    To identify any predictor of the recurrence of systemic symptoms after discontinuation of hymenoptera venom immunotherapy, among the above listed parameters.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

La désensibilisation Aux Venins d'hyménoptères : Quelle Est Son efficacité à Long Terme ? (EFLOTITA2)

Acronym: EFLOTITA2

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2022
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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