De-labeling of Patients With False Diagnosis of Penicillin Allergy

Allergy Drug Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03581604
• Other study ID #: 2017/2119/REK
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: Eva Stylianou, Phd
• Phone: 004722118784
• Email: eva.stylianou[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy Drug
• Hypersensitivity

Intervention

Diagnostic Test:
• Allergy work-up
Allergy work-up

Other:
• Blood samples
Blood samples

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål	Oslo	Postbox 4950 Nydalen

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Penicillin allergy in the studied group	Frequency of true penicillin allergy in the study group	up to 4 years
Primary	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	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