De-labeling of Patients With False Diagnosis of Penicillin Allergy

NCT ID: NCT03581604

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-13
• Study Completion Date: 2026-12-31

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.

Conditions

Allergy Drug

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients labeled as penicillin allergic

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.

Group Type: OTHER

Allergy work-up

Intervention Type: DIAGNOSTIC_TEST

Allergy work-up

Blood samples

Intervention Type: OTHER

Blood samples

Interventions

Allergy work-up

Allergy work-up

Intervention Type: DIAGNOSTIC_TEST

Blood samples

Blood samples

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eva Stylianou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Stylianou, Phd

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål

Oslo, Postbox 4950 Nydalen, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Eva Stylianou, Phd

Role: CONTACT

eva.stylianou@ous-hf.no

004722118784

Facility Contacts

Eva Stylianou, PHD

Role: primary

eva.stylianou@ous-hf.no

004722118784

Other Identifiers

2017/2119/REK

Identifier Type: -

Identifier Source: org_study_id