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

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

Study Overview

• Status: Recruiting
• Conditions: Anaphylaxis Caused by Hymenoptera Venom (Disorder)
• Intervention / Treatment: Other: Telephone survey

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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• France
  • Maine Et Loire
    • Angers, Maine Et Loire, France, 49100
      • Recruiting
      • University Hospital of Angers
      • Contact: MARTINE MORISSET, MD, PhD; Phone Number: +33241353551; Email: martine.morisset@chu-angers.fr
      • Contact: PRINCY BERIZIKY, MD; Phone Number: +33241353551; Email: princy.beriziky@chu-angers.fr
      • Principal Investigator: MARTINE MORISSET, MD, PHD
      • Sub-Investigator: PRINCY BERIZIKY, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Included; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reccurence of a systemic reaction	The recurrence of a systemic reaction after a hymenoptera sting reported by the patient during the telephone survey.	up to 17 years since the patient ceased hymenoptera venom immunotherapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the evolution of the results of the allergy work-up during hymenoptera venom immunotherapy	Results of skin-testing and blood work	up to 17 years since the patient ceased hymenoptera venom immunotherapy to the last appointement in the allergy unit.
Predicting the recurrence of systemic symptoms	To identify any predictor of the recurrence of systemic symptoms after discontinuation of hymenoptera venom immunotherapy, among the above listed parameters.	up to 17 years since the patient ceased hymenoptera venom immunotherapy until the phone survey

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (ACTUAL): April 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: hymenoptera venom immunotherapy; anaphylaxis; venom allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Anaphylaxis
• Other Study ID Numbers: 49RC20_0158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No