De-labeling of Patients With False Diagnosis of Penicillin Allergy (NCT03581604) | Clinical Trial Compass
CompletedNot Applicable
De-labeling of Patients With False Diagnosis of Penicillin Allergy
Norway155 participantsStarted 2017-09-13
Plain-language summary
The purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients who are referred to the department of Pulmonary medicine with clinical history suspected of having penicillin allergy.
* The control group will be healthy adult volunteers with no history of any personal or family history of drug allergy, atopy, inflammatory or autoimmune diseases.
Exclusion Criteria:
* Systemic reactions such as DRESS, any internal organ involvement
* Clinical history of Type II-III hypersensitivity reaction
* Severe Type IV hypersensitivity reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, vasculitis, acute generalized exanthematous pustulosis
* Chronic idiopathic urticaria on antihistamine maintenance treatment/anti-IgE treatment
* Medication which can affect the test outcome
* Active signs of an underlying disease such as uncontrolled asthma
* Cardiac disease with increased risk of serious anaphylaxis
* Pregnancy/Breastfeeding
* Reaction within the last 4-6 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of Penicillin allergy in the studied group