Penicillin Allergy Delabeling Project

  • STATUS
    Recruiting
  • End date
    Jul 1, 2026
  • participants needed
    100
  • sponsor
    Haukeland University Hospital
Updated on 30 October 2021
Accepts healthy volunteers

Summary

A investigational study to establish:

  1. A validated risk stratification tool for patients labeled Penicillin allergic.
  2. Facilitate provocation test for delabeling of Penicillin allergy outside an allergologic clinic
  3. Examine the gut microbiome of penicillin allergic patients

Description

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.

Details
Condition allergy to penicillin, Penicillin Allergy
Treatment Risk Stratification
Clinical Study IdentifierNCT05090527
SponsorHaukeland University Hospital
Last Modified on30 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Penicillin allergy in the patient journal oder patient reported

Exclusion Criteria

Not able to give concent. Under 16 years of age
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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