Allergy Testing of Soldiers Prepared for International Mission (SPAT_ABL)

March 28, 2023 updated by: Ilan Baron, Queen Astrid Military Hospital

Validation of the Benefit of Allergy Testing of Soldiers Prepared for International Mission With Specific Allergen Panels

The goal of this prospective mono centric study is to identify relevant commercially available allergen extracts for allergy testing in soldiers prepared for international mission.

Participants will receive a skin prick test with the skin prick automated test device including 22 allergens and 2 controls on both forearms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1120
        • Recruiting
        • Military Hospital Queen Astrid
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult military personnel (18-65y) will be included. Soldiers with and without previous exposure to allergens in the regions of interest will be included. Soldiers who are performing desk tasks and not selected for international missions will serve as controls.

Exclusion Criteria:

  • Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
  • Use of antihistaminic medication < 7 days before the start of the study
  • Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study
  • Use of topical corticoids on the forearm < 7 days before the start of the study
  • Use of Omalizumab < 6 months before the start of the study
  • Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Skin Prick Automated Test
Device: Skin Prick Automated Test
A skin prick automated test will be performed in each participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allergens with positive skin reaction
Time Frame: baseline
Positive skin reactions of top ranked allergens required to identify 95% of sensitised individuals
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported allergic diseases
Time Frame: baseline
Percentage of soldiers with self-reported allergic diseases derived from questionnaire
baseline
Work Performance & Activity Impairment
Time Frame: baseline
Total score of Work Performance & Activity Impairment questionnaire, 0-100%, higher score means worse outcome
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Astrid Military Hospital

Investigators

  • Principal Investigator: Ilan Baron, MD, Military Hospital Queen Astrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22467

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Adult Military Personnel

Clinical Trials on Skin Prick Automated Test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe