De-labeling of Patients With False Diagnosis of Penicillin Allergy

University of Oslo (UIO)

Status: Enrolling

Conditions: Allergy Drug

Treatments: Diagnostic Test: Allergy work-up; Other: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03581604

2017/2119/REK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients labeled as penicillin allergic

Other group

Description:

Patients labeled as penicillin allergic will be allergologically investigated to confirm/exclude the diagnosis. Allergy work-up will be performed. Blood samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention.

Treatment:

Other: Blood samples

Diagnostic Test: Allergy work-up