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Allergy Testing of Soldiers Prepared for International Mission (SPAT_ABL)

Primary Purpose

Adult Military Personnel

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Skin Prick Automated Test
Sponsored by
Queen Astrid Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adult Military Personnel

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Military Hospital Queen AstridRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skin Prick Automated Test

Arm Description

Outcomes

Primary Outcome Measures

Allergens with positive skin reaction
Positive skin reactions of top ranked allergens required to identify 95% of sensitised individuals

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2023
Last Updated
March 28, 2023
Sponsor
Queen Astrid Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05807958
Brief Title
Allergy Testing of Soldiers Prepared for International Mission
Acronym
SPAT_ABL
Official Title
Validation of the Benefit of Allergy Testing of Soldiers Prepared for International Mission With Specific Allergen Panels
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Astrid Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Military Personnel

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skin Prick Automated Test
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Skin Prick Automated Test
Intervention Description
A skin prick automated test will be performed in each participant.
Primary Outcome Measure Information:
Title
Allergens with positive skin reaction
Description
Positive skin reactions of top ranked allergens required to identify 95% of sensitised individuals
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Self-reported allergic diseases
Description
Percentage of soldiers with self-reported allergic diseases derived from questionnaire
Time Frame
baseline
Title
Work Performance & Activity Impairment
Description
Total score of Work Performance & Activity Impairment questionnaire, 0-100%, higher score means worse outcome
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Baron, MD
Phone
+32 22575173
Email
drbaron.be@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Baron, MD
Organizational Affiliation
Military Hospital Queen Astrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military Hospital Queen Astrid
City
Brussels
ZIP/Postal Code
1120
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilan Baron, MD
Phone
+32 22575173
Email
drbaron.be@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36495473
Citation
Gorris S, Uyttebroek S, Backaert W, Jorissen M, Schrijvers R, Thompson MJ, Loeckx D, Seys SF, Van Gerven L, Hellings PW. Reduced intra-subject variability of an automated skin prick test device compared to a manual test. Allergy. 2023 May;78(5):1366-1368. doi: 10.1111/all.15619. Epub 2022 Dec 26. No abstract available.
Results Reference
result

Learn more about this trial

Allergy Testing of Soldiers Prepared for International Mission

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