Penicillin Allergy Delabeling Project
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- STATUS
- Recruiting
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- End date
- Jul 1, 2026
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- participants needed
- 100
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- sponsor
- Haukeland University Hospital
Summary
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
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 Identifier | NCT05090527 |
| Sponsor | Haukeland University Hospital |
| Last Modified on | 30 October 2021 |
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