Study Results
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Basic Information
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COMPLETED
NA
153 participants
INTERVENTIONAL
2021-07-28
2023-05-01
Brief Summary
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1. A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments.
2. A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling.
3. A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians.
2\. Implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the Western Norway health region.
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Detailed Description
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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.
To implement such pathways i qualitative data is needed to facilitate the right efforts and translate the method into every day clinical practice in a sustainable way. Here a anesthesiologist survey and focus group interviews with hospital nurses and physichians is planned.
Finally we will implement the method in an implementation study across the Western Norway Health region
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Directly delabeled trough risk stratification tool
Patients who are stratified as " no penicillin allergy" undergo a one dose full dose provocation test with 500 mg amoxicillin.
Risk stratification
advanced penicillin challenge after risk stratification
Low risk patients
Patients stratified as low risk on penicillin provocation undergo a one dose full dose provocation test with 500mg amoxicillin
Risk stratification
advanced penicillin challenge after risk stratification
High risk
Patient stratified as high risk undergo a full allergologic work up, and only some of these will undergo a provocation test.
Risk stratification
advanced penicillin challenge after risk stratification
Interventions
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Risk stratification
advanced penicillin challenge after risk stratification
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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Helse Fonna
OTHER
Helse Forde
OTHER
Haraldsplass Deaconess Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Torgeir Storaas, phd
Role: STUDY_CHAIR
RAAO vest
Locations
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Haukeland University Hospital
Bergen, , Norway
Helse Førde
Førde, , Norway
Countries
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References
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Alnaes MB, Oppegaard O, Kittang BR, Lygre SHL, Langeland AB, Skodvin B, Bjanes T, Storaas T. A new pathway for penicillin delabeling in Norway. World Allergy Organ J. 2023 Oct 16;16(11):100829. doi: 10.1016/j.waojou.2023.100829. eCollection 2023 Nov.
Other Identifiers
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199210
Identifier Type: -
Identifier Source: org_study_id
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