Penicillin Allergy Delabeling Project

Study Overview
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Brief Summary
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A investigational study to establish: A validated risk stratification tool for patients labeled Penicillin allergic. Facilitate provocation test for delabeling of Penicillin allergy outside an allergologic clinic Examine the gut microbiome of penicillin allergic patients

Detailed Description
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Patients labeled penicillin allergic is a significant and growing public health problem. 10% of all patients report penicillin allergy. 9 out of 10 however tolerate penicillin on provocation, To be labeled as penicillin allergic has several well documented negative health outcomes for the individual, and on a public health scale. One of the biggest obstacles in delabeling penicillin allergy is the lack of validated tools i Norwegian, the lack of in vitro tests for severe late /T cell mediated reactions and the accessibility of the gold standard procedure, drug provocation test. In this study patients having a penicillin allergy label will after giving their written concent be screened used a risk stratification tool. The low risk patient will then directly undergo a single full dose amoxicillin challenge. High risk patients are refered to a allergologic clinic and undergoes full allergologic examination. The investigators seek to document that in low risk patients is a single dose Amoxicillin challenge safe and beneficial outside an allergologic clinic, and to validate the risk stratification tool in Norwegian. The investigators want to examine the gut microbiome of patients labeled penicillin allergic. Changes in the gut microbiome can be temporarily and permanent, and selected microbiome profiles has shown to influence the health outcome of patients. Little is known about the impact on the gut microbiome in patients labeled penicillin allergic and the examinators seek to examine this, and correlate data with known risk profiles in gut microbiome.

Official Title
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Penicillin Delabeling With Help of a Risk Stratification Tool, Advanced Provocation Tests in a Non Allergologic Unit and Examination of the Gut Microbiota in Patients Labeled Penicillin Allergic

Conditions
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Penicillin Allergy

Intervention / Treatment
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* Diagnostic Test: Risk stratification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Penicillin allergy in the patient journal oder patient reported Exclusion Criteria: Not able to give concent. Under 16 years of age.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Entry criteria: Penicillin allergy noted in patients journal or patient reported.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Directly delabeled trough risk stratification tool<br>Patients who are stratified as  no penicillin allergy undergo a one dose full dose provocation test with 500 mg amoxicillin. | Diagnostic Test: Risk stratification<br>* advanced penicillin challenge after risk stratification<br>|
| Active Comparator: Low risk patients<br>Patients stratified as low risk on penicillin provocation undergo a one dose full dose provocation test with 500mg amoxicillin | Diagnostic Test: Risk stratification<br>* advanced penicillin challenge after risk stratification<br>|
| Active Comparator: High risk<br>Patient stratified as high risk undergo a full allergologic work up, and only some of these will undergo a provocation test. | Diagnostic Test: Risk stratification<br>* advanced penicillin challenge after risk stratification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge | Negative predictive value of the risk stratification tool | trough study completion up to 3 years | 
| Analyzing the effects of risk stratification and advanced drug provocation | Change in number of patients with antibiotic treatment in line with government recommendation. | Trough study completion up to 5 years | 
| Analyzing the gut microbiome of patient labeled penicillin allergic | Map the gut microbiota profile in patients labeled penicillin allergic with 16S rRibosomal ribonucleic acid sequencing. | through study completion up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in days submitted to hospital before and after delabeling in the current ward. | number of days submittet to hospital | Through study completion up to 3 years | 
| Number of patients with treatment related adverse events on oral provocation testing. | number of patients with treatment related adverse event on oral provocation testing. | trough study completion up to 3 years |