Evaluating and potentially removing false penicillin allergy labels
Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance
This study is testing if people who have been told they are allergic to penicillin can actually tolerate the medication and how accurate the tests for this allergy are.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo, Postbox 4950 Nydalen) |
| Trial ID | NCT03581604 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of penicillin allergy and the effectiveness of diagnostic tests used to confirm or exclude this allergy. It focuses on patients who have been labeled as allergic to penicillin, investigating their actual tolerance to the medication through a comprehensive allergologic work-up and clinical assessments. The study will also analyze immunological parameters to better understand the health implications of a penicillin allergy diagnosis.
Who should consider this trial
Good fit: Ideal candidates include adult patients referred for suspected penicillin allergy based on clinical history.
Not a fit: Patients with a history of severe allergic reactions or specific hypersensitivity syndromes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help many patients avoid unnecessary restrictions on their medication options and improve their treatment outcomes.
How similar studies have performed: Other studies have indicated that many patients labeled with penicillin allergies can tolerate the drug, suggesting that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oslo, Postbox 4950 Nydalen
- Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål — Oslo, Postbox 4950 Nydalen, Norway (Recruiting)
Study contacts
- Principal investigator: Eva Stylianou, Phd — Oslo University Hospital
- Study coordinator: Eva Stylianou, Phd
- Email: eva.stylianou@ous-hf.no
- Phone: 004722118784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.