De-labeling of Patients With False Diagnosis of Penicillin Allergy

Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance

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.

Study Overview

• Status: Completed
• Conditions: Allergy Drug
• Intervention / Treatment: Diagnostic test: Allergy work-up; Other: Blood samples

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Postbox 4950 Nydalen
    • Oslo, Postbox 4950 Nydalen, Norway, 0424
      • Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Diagnostic test: Allergy work-up; Allergy work-up; Other: Blood samples; Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Penicillin allergy in the studied group	Frequency of true penicillin allergy in the study group	up to 4 years
Negative predictive value of the allergy work- up	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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.	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?"	12 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Eva Stylianou, Phd, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Penicillin/b-lactams
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Drug Hypersensitivity; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 2017/2119/REK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No