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De-labeling of Patients With False Diagnosis of Penicillin Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03581604
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Eva Stylianou, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Allergy Drug Diagnostic Test: Allergy work-up Other: Blood samples and microbiological samples. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient group consisting of patients labeled as penicillin allergic and a controll group of healthy volunteers
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Penicillins

Arm Intervention/treatment
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 and Microbiological samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention.
Diagnostic Test: Allergy work-up
Allergy work-up

Other: Blood samples and microbiological samples.
Blood samples and microbiological samples

Healthy Controls
Healthy Controls, blood samples and microbiological samples.Clinical history
Other: Blood samples and microbiological samples.
Blood samples and microbiological samples

Primary Outcome Measures :
  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 Outcome Measures :
  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?"

  2. Prevalence of multidrug resistant bacteria and use of broad spectrum antibiotics in patients labeled as penicillin allergic [ Time Frame: up to 4 years ]
    Prevalence of multidrug resistant bacteria by bacterial culture from nostriles. Register the use of broad spectrum antibiotics in patients that have been treated with antibiotics prior to allergy work-up.

  3. Immune phenotype of penicillin allergic patients by determination of cytokine/chemokine levels. [ Time Frame: up to 4 years ]
    Measurement of cytokine/chemokine levels in blood samples.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03581604

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Contact: Eva Stylianou, Phd 004722118784

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Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål Recruiting
Oslo, Postbox 4950 Nydalen, Norway, 0424
Contact: Eva Stylianou, PHD    004722118784   
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Eva Stylianou, Phd Oslo University Hospital

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Responsible Party: Eva Stylianou, Principal Investigator, Oslo University Hospital Identifier: NCT03581604    
Other Study ID Numbers: 2017/2119/REK
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eva Stylianou, Oslo University Hospital:
Additional relevant MeSH terms:
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Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents