Allergy Drug
Conditions
Keywords
Penicillin/b-lactams
Brief 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.
Detailed description
Penicillin allergy is the most common of self-reported drug allergies and un-verified penicillin allergy is a significant and growing public health problem. 10% of all patients report penicillin allergy. However, there is large discrepancy between reported penicillin allergy and true allergy. Despite its high prevalence, greater than 90% of such patients are in fact able to tolerate the medication without allergic reactions. In this study patients having a penicillin allergy label will be investigated to confirm or to exclude the allergy diagnosis. The diagnostic value of the allergen test panel and the allergologic work-up will be evaluated. Clinical parameters as well as immunological will be assessed.
Interventions
DIAGNOSTIC_TESTAllergy work-up
Allergy work-up
OTHERBlood samples
Blood samples
Sponsors
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Patient group consisting of patients labeled as penicillin allergic.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Penicillin allergy in the studied group | up to 4 years | Frequency of true penicillin allergy in the study group |
| Negative predictive value of the allergy work- up | 3 weeks | If the allergy work-up is negative, drug provocation test with penicillin will be performed. The purpose of the drug challenge is to confirm lack of allergy and confirm the negative predictive value of the allergy work-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing. | 12 months | Patients going through an allergy workup with negative results, will be retrospectively contacted within one year after investigation. Telephone interview where the following questions will be asked:1) "Have you received antibiotic therapy since being seen in the allergy clinic?" 2) "If you have been treated, what drug did you take?" 3) "As a result of this, did you have a reaction to the antibiotics?" "If yes, what kind of reaction have you developed?" 4) "If you didn't take the drug you were challenged with what was the reason for that?" |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATOREva Stylianou, Phd
Oslo University Hospital
Outcome results
None listed