Penicillin Allergy Delabeling Project

Not Applicable

Completed

• Conditions: Penicillin Allergy

• Registration Number: NCT05090527
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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.

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

Detailed 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

Study Timeline

• Study Start: 2021-07-28
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-10-22
• Primary Completion: 2023-04-01
• Study Completion: 2023-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Penicillin allergy in the patient journal oder patient reported

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge	24 months	Negative predictive value of the risk stratification tool

Secondary Outcome Measures

Name	Time	Method
Number of patients with treatment related adverse events on oral provocation testing.	24 months	number of patients with treatment related adverse event on oral provocation testing.
Number of patients correctly delabeled	24 months	Og the patientents included in the implementation in clinical practice, how many had a correct procedure and result.

Trial Locations

Locations (2)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Helse Førde; 🇳🇴 Førde, Norway