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Completed

NCT Number: NCT03581604

De-labeling of Patients With False Diagnosis of Penicillin Allergy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål

Oslo, Postbox 4950 Nydalen, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allergy work-up

Diagnostic Test

Allergy work-up

Blood Samples

Other

Blood samples

Primary outcomes

  1. Prevalence of Penicillin allergy in the studied group

    Time frame: up to 4 years

    Frequency of true penicillin allergy in the study group

  2. Negative predictive value of the allergy work- up

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.

    Time frame: 12 months

    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?"

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jul 10, 2018
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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