Clinical trial NCT03581604: De-labeling of Patients With False Diagnosis of Penicillin Allergy
Official title: Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergy Drug
Keywords: Penicillin/b-lactams
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient group consisting of patients labeled as penicillin allergic.
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of Penicillin allergy in the studied group
timeFrame: up to 4 years
measure: Negative predictive value of the allergy work- up
timeFrame: 3 weeks
Secondary outcomes:
measure: Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål
state: Postbox 4950 Nydalen
Study officials:
affiliation: Oslo University Hospital
name: Eva Stylianou, Phd
role: PRINCIPAL_INVESTIGATOR
References: