Alleged Drug Allergies in Military General Medicine: Patients' Experiences and Beliefs (ALLMED)

Alleged Drug Allergies in Military General Medicine: Patients' Experiences and Beliefs (ALLMED)

This study focuses on the experience of the military patient reporting a suspected drug allergy, with its own specificities. Suspicions of drug allergies during a mission expose the doctor to difficulties.

This study will improve understanding of the allergy patient's point of view. The end result could be a set of ideas for measures to raise awareness among these patients, and motivate them to undergo an allergological assessment.

Study Overview

• Status: Recruiting
• Conditions: Allergy Penicillin
• Intervention / Treatment: Other: Interview

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: BLANCHET; Phone Number: 01.39.67.60.54; Email: marie-laure.blanchet@intradef.gouv.fr

Study Locations

• France
  • Versailles, France, 78013
    • Recruiting
    • 15ème antenne médicale - Camp des Matelots
    • Contact: BLANCHET; Phone Number: 01.39.67.60.54; Email: marie-laure.blanchet@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Military personnel reporting a drug allergy to antibiotics

Description

Inclusion Criteria:

• Military personnel (active or reservist)
• Reporting a drug allergy during a periodic medical check-up or during a consultation in a medical unit
• Not opposed to participating in the study.

Exclusion Criteria:

• Candidate on admission visit
• Opposition to study
• Minor (under 18 years of age)
• Pregnant, parturient or breast-feeding woman
• Person deprived of liberty by a judicial or administrative decision, person under psychiatric care
• Non-French nationals
• Person of full age subject to a legal protection measure
• Person unable to express non-opposition

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Interview; Monocentric qualitative study with a descriptive socio-demographic section, a descriptive qualitative section on the experience and perception of allergy, then on the obstacles to allergological assessment, and finally a descriptive quantitative section to evaluate knowledge of antibiotic therapy.	Other: Interview; Semi-structured interview on experiences, perceptions, beliefs and knowledge of drug allergy and barriers to allergological testing, with a view to content analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' experiences of drug allergies	describe patients' experiences, perceptions, beliefs and knowledge of drug allergies in general practice in the army	Through study completion (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' obstacles	describe the obstacles to allergological assessment	Through study completion (12 months)

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity
• Other Study ID Numbers: 2022PPRC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No