Penicillin Allergy Delabeling Project (PenProv)

Haukeland University Hospital

Status: Completed

Conditions: Penicillin Allergy

Treatments: Diagnostic Test: Risk stratification

Study type: Interventional

Funder types: Other

Identifiers

NCT05090527

199210

Details and patient eligibility

About

A investigational study to establish:

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.

4. Implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the Western Norway health region.

Full 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.

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

Enrollment: 153 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Penicillin allergy in the patient journal oder patient reported

Exclusion criteria

• Not able to give concent. Under 16 years of age.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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153 participants in 3 patient groups

Directly delabeled trough risk stratification tool

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Risk stratification

Low risk patients

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Risk stratification

High risk

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Risk stratification