The Causative Insects in Severe Insect Sting Allergy
Primary Purpose
Insect Sting Allergy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Skin prick test
sIgE measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Insect Sting Allergy focused on measuring insect sting allergy, recombinant venom allergen
Eligibility Criteria
Inclusion Criteria:
- Cases with severe insect sting allergy reactions
Exclusion Criteria:
- Without other severe systemic diseases
- Not pregnant or lactation
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
insect sting allergy
Arm Description
Skin prick tests to local and imported insect sting allergen with different concentration are performed. sIgE Measurement (to insect and the recombinant venom)
Outcomes
Primary Outcome Measures
Mean wheal diameters of skin prick test of local and imported insect allergens
Compare Mean wheal diameters of skin prick test of local and imported insect allergens at different concentrations
Secondary Outcome Measures
specific IgE level to stinging insect allergen and recombinant venom allergens
compare skin prick test result and levels of specific IgE level to stinging insect allergen and recombinant venom allergens
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02764242
Brief Title
The Causative Insects in Severe Insect Sting Allergy
Official Title
Evaluating the Causative Insects in the Cases With Severe Insect Sting Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study the causative insect by skin prick test and sIgE to wasp, bee and fire ants are important but false positive by crossreactivity can occur. sIgE to recombinant venom allergen is proposed to help in finding the causative insect.
Detailed Description
Insect sting allergy from insects in Hymenoptera is not uncommon. The reaction maybe very severe and life threatening. To find the cause of insect sting allergy is important in prevention and specific treatment such as immunotherapy. The skin prick test and sIgE of these insects may have cross reactions so it is difficult to be interpreted.
The usage of sIgE recombinant venom allergen can benefit in separate cross reaction and dual allergy reaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insect Sting Allergy
Keywords
insect sting allergy, recombinant venom allergen
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
insect sting allergy
Arm Type
Other
Arm Description
Skin prick tests to local and imported insect sting allergen with different concentration are performed.
sIgE Measurement (to insect and the recombinant venom)
Intervention Type
Other
Intervention Name(s)
Skin prick test
Intervention Description
Skin prick tests to local and imported insect sting allergen with different concentration are performed.
Intervention Type
Other
Intervention Name(s)
sIgE measurement
Intervention Description
sIgE levels to stinging insect allergen and their recombinant venom allergen are measured
Primary Outcome Measure Information:
Title
Mean wheal diameters of skin prick test of local and imported insect allergens
Description
Compare Mean wheal diameters of skin prick test of local and imported insect allergens at different concentrations
Time Frame
12 months
Secondary Outcome Measure Information:
Title
specific IgE level to stinging insect allergen and recombinant venom allergens
Description
compare skin prick test result and levels of specific IgE level to stinging insect allergen and recombinant venom allergens
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cases with severe insect sting allergy reactions
Exclusion Criteria:
Without other severe systemic diseases
Not pregnant or lactation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Causative Insects in Severe Insect Sting Allergy
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