- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02764242
The Causative Insects in Severe Insect Sting Allergy
Evaluating the Causative Insects in the Cases With Severe Insect Sting Allergy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cases with severe insect sting allergy reactions
Exclusion Criteria:
- Without other severe systemic diseases
- Not pregnant or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: insect sting allergy
Skin prick tests to local and imported insect sting allergen with different concentration are performed. sIgE Measurement (to insect and the recombinant venom) |
Skin prick tests to local and imported insect sting allergen with different concentration are performed.
sIgE levels to stinging insect allergen and their recombinant venom allergen are measured
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean wheal diameters of skin prick test of local and imported insect allergens
Time Frame: 12 months
|
Compare Mean wheal diameters of skin prick test of local and imported insect allergens at different concentrations
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
specific IgE level to stinging insect allergen and recombinant venom allergens
Time Frame: 12 months
|
compare skin prick test result and levels of specific IgE level to stinging insect allergen and recombinant venom allergens
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Si063/2557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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