Allergy PenicillinALLMEDNCT06112470
Alleged Drug Allergies in Military General Medicine: Patients' Experiences and Beliefs
An observational study of Allergy Penicillin, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy Penicillin
- What is being tested?
- Interview
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2023to Mar 2024
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Military personnel reporting a drug allergy to antibiotics
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
15ème antenne médicale - Camp des Matelots
Versailles, 78013
BLANCHET, 01.39.67.60.54, marie-laure.blanchet@intradef.gouv.fr
About this study
Official title: 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.
- Conditions
- Allergy Penicillin
- Being tested
- Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Semi-structured interview on experiences, perceptions, beliefs and knowledge of drug allergy and barriers to allergological testing, with a view to content analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' experiences of drug allergies
describe patients' experiences, perceptions, beliefs and knowledge of drug allergies in general practice in the army
Measured: Through study completion (12 months)
Secondary outcomes (1)
Patients' obstacles
describe the obstacles to allergological assessment
Measured: Through study completion (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start28 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy PenicillinStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112470
- Sponsor's protocol ID
- 2022PPRC02
- Acronym
- ALLMED
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleged Drug Allergies in Military General Medicine: Patients' Experiences and Beliefs (ALLMED)
- ClinicalTrials.gov ID
- NCT06112470
- Acronym / sponsor ID
- ALLMED / 2022PPRC02
- Conditions
- Allergy Penicillin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Nov 2023 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview | – | Other: InterviewMonocentric 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Military personnel reporting a drug allergy to antibiotics
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| InterviewSemi-structured interview on experiences, perceptions, beliefs and knowledge of drug allergy and barriers to allergological testing, with a view to content analysis. | Other | Interview |
Primary outcome
Patients' experiences of drug allergies
Time frame: Through study completion (12 months)
describe patients' experiences, perceptions, beliefs and knowledge of drug allergies in general practice in the army
1 secondary outcome
Patients' obstacles
Time frame: Through study completion (12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy Penicillin, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BLANCHET (01.39.67.60.54, marie-laure.blanchet@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' experiences of drug allergies (time frame: Through study completion (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 1 Nov 2023.