Penicillin Allergy Delabeling Project (PenProv)

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

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

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.

None, open provocation test with amoxicillin for eligible patients after risk stratification with a questionnaire.

Patients who are stratified as " no penicillin allergy" undergo a one dose full dose provocation test with 500 mg amoxicillin.

Patients stratified as low risk on penicillin provocation undergo a one dose full dose provocation test with 500mg amoxicillin

Patient stratified as high risk undergo a full allergologic work up, and only some of these will undergo a provocation test.

Map the gut microbiota profile in patients labeled penicillin allergic with 16S rRibosomal ribonucleic acid sequencing.

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

Regionalt senter for astma, allergi og annen overfølsomhet i Helse vest, Haukeland universitetssjukehus