Insect Sting AllergyNCT02764242
The Causative Insects in Severe Insect Sting Allergy
A study testing Skin prick test and sIgE measurement in people with Insect Sting Allergy, run by Mahidol University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insect Sting Allergy
- What is being tested?
- Skin prick test and sIgE measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- 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
Who may be able to join
- Cases with severe insect sting allergy reactions
Who cannot join
- Without other severe systemic diseases
- Not pregnant or lactation
About this study
Official title: Evaluating the Causative Insects in the Cases With Severe Insect Sting Allergy
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.
Read the 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.
- Conditions
- Insect Sting Allergy
- Being tested
- Skin prick test, sIgE measurement
- Keywords
- insect sting allergy, recombinant venom allergen
- Medical subject headings
- Venom Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick testOther
Skin prick tests to local and imported insect sting allergen with different concentration are performed.
sIgE measurementOther
sIgE levels to stinging insect allergen and their recombinant venom allergen are measured
| Study group | Role | What they receive |
|---|---|---|
| insect sting allergy | Other | Skin prick tests to local and imported insect sting allergen with different concentration are performed.
sIgE Measurement (to insect and the recombinant venom) Receives: Other: Skin prick test; Other: sIgE measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insect Sting AllergyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764242
- Sponsor's protocol ID
- Si063/2557
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Causative Insects in the Cases With Severe Insect Sting Allergy
- ClinicalTrials.gov ID
- NCT02764242
- Acronym / sponsor ID
- Si063/2557
- Conditions
- Insect Sting Allergy
- Keywords
- insect sting allergy, recombinant venom allergen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insect sting allergy | Other | Other: Skin prick test, Other: sIgE measurementSkin prick tests to local and imported insect sting allergen with different concentration are performed. sIgE Measurement (to insect and the recombinant venom) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cases with severe insect sting allergy reactions
Key exclusion criteria (2 listed)
- Without other severe systemic diseases
- Not pregnant or lactation
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 |
|---|---|---|
| Skin prick testSkin prick tests to local and imported insect sting allergen with different concentration are performed. | Other | insect sting allergy |
| sIgE measurementsIgE levels to stinging insect allergen and their recombinant venom allergen are measured | Other | insect sting allergy |
Primary outcome
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
1 secondary outcome
specific IgE level to stinging insect allergen and recombinant venom allergens
Time frame: 12 months
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 6 May 2016.
- Individual participant dataSharing planned: No
Related trials for Insect Sting Allergy
RecruitingObservational study
Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
Allergy, Insect Venom, Allergy Insect Stinging
RecruitingObservational study
Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Allergy, Insect Venom, Allergy Insect Stinging
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.
Questions about this trial
What is this clinical trial studying?
A study testing Skin prick test and sIgE measurement in people with Insect Sting Allergy, run by Mahidol University.
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 1 inclusion and 2 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 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean wheal diameters of skin prick test of local and imported insect allergens (time frame: 12 months). 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 6 May 2016.