Ignite Creation Date:
2024-05-06 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05311644
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2022-01-31
Brief Title:
Hymenoptera Venom Immunotherapy Evaluation of Its Long-term Efficacy at the University Hospital of Angers EFLOTITA2
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
La désensibilisation Aux Venins dhyménoptères Quelle Est Son efficacité à Long Terme EFLOTITA2
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFLOTITA2
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
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 participants 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
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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None