Anaphylaxis Caused by Hymenoptera Venom (Disorder)EFLOTITA2NCT05311644
Hymenoptera Venom Immunotherapy: Evaluation of Its Long-term Efficacy at the University Hospital of Angers (EFLOTITA2)
An observational study of Anaphylaxis Caused by Hymenoptera Venom (Disorder), run by University Hospital, Angers at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anaphylaxis Caused by Hymenoptera Venom (Disorder)
- What is being tested?
- Telephone survey
- How many people
- 290 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2022to 14 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Allergy to hymenoptera venom, Treated with VIT at the university hospital of Angers, Ceased VIT between 2005 and 2019
Who may be able to join
- Allergy to hymenoptera venom.
- Treated with VIT at the university hospital of Angers.
- Ceased VIT between 2005 and 2019.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Telephone survey
- Keywords
- hymenoptera venom immunotherapy; anaphylaxis; venom allergy
- Medical subject headings
- Anaphylaxis, Venom Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone surveyOther
All participants are interviewed by telephone, and are asked to answer a survey.
| Study group | Role | What they receive |
|---|---|---|
| Included | All participants that cesed VIT between 2005 and 2019, and did not withdraw his consent to participate to the study. Receives: Other: Telephone survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reccurence of a systemic reaction
The recurrence of a systemic reaction after a hymenoptera sting reported by the patient during the telephone survey.
Measured: up to 17 years since the patient ceased hymenoptera venom immunotherapy.
Secondary outcomes (2)
To describe the evolution of the results of the allergy work-up during hymenoptera venom immunotherapy
Results of skin-testing and blood work
Measured: 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.
Measured: up to 17 years since the patient ceased hymenoptera venom immunotherapy until the phone survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start14 Apr 2022
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaphylaxis Caused by Hymenoptera Venom (Disorder)Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311644
- Sponsor's protocol ID
- 49RC20_0158
- Acronym
- EFLOTITA2
- Status last verified
- Jul 2025
- First submitted
- 31 Jan 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- La désensibilisation Aux Venins d'hyménoptères : Quelle Est Son efficacité à Long Terme ? (EFLOTITA2)
- ClinicalTrials.gov ID
- NCT05311644
- Acronym / sponsor ID
- EFLOTITA2 / 49RC20_0158
- Keywords
- hymenoptera venom immunotherapy; anaphylaxis; venom allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included | – | Other: Telephone surveyAll participants that cesed VIT between 2005 and 2019, and did not withdraw his consent to participate to the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Allergy to hymenoptera venom, Treated with VIT at the university hospital of Angers, Ceased VIT between 2005 and 2019
Key inclusion criteria (3 listed)
- Allergy to hymenoptera venom.
- Treated with VIT at the university hospital of Angers.
- Ceased VIT between 2005 and 2019.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone surveyAll participants are interviewed by telephone, and are asked to answer a survey. | Other | Included |
Primary outcome
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.
2 secondary outcomes
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.
Predicting the recurrence of systemic symptoms
Time frame: up to 17 years since the patient ceased hymenoptera venom immunotherapy until the phone survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis Caused by Hymenoptera Venom (Disorder), run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reccurence of a systemic reaction (time frame: up to 17 years since the patient ceased hymenoptera venom immunotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.