NCT02764242

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

May 4, 2016

Last Update Submit

May 4, 2016

Conditions

Insect Sting Allergy

Keywords

insect sting allergyrecombinant venom allergen

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (1)

  • specific IgE level to stinging insect allergen and recombinant venom allergens

    12 months

Study Arms (1)

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)

Other: Skin prick testOther: sIgE measurement

Interventions

Skin prick testOTHER

Skin prick tests to local and imported insect sting allergen with different concentration are performed.

insect sting allergy
sIgE measurementOTHER

sIgE levels to stinging insect allergen and their recombinant venom allergen are measured

insect sting allergy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cases with severe insect sting allergy reactions

You may not qualify if:

  • Without other severe systemic diseases
  • Not pregnant or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venom Hypersensitivity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share