Penicillin Allergy Delabeling Project (PenProv)

Penicillin Delabeling With Help of a Risk Stratification Tool, Advanced Provocation Tests in a Non Allergologic Unit

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.

Study Overview

• Status: Completed
• Conditions: Penicillin Allergy
• Intervention / Treatment: Diagnostic test: Risk stratification

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Førde, Norway
    • Helse Førde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Penicillin allergy in the patient journal oder patient reported

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Diagnostic test: Risk stratification; advanced penicillin challenge after risk stratification
Active Comparator: Low risk patients; Patients stratified as low risk on penicillin provocation undergo a one dose full dose provocation test with 500mg amoxicillin	Diagnostic test: Risk stratification; advanced penicillin challenge after risk stratification
Active Comparator: High risk; Patient stratified as high risk undergo a full allergologic work up, and only some of these will undergo a provocation test.	Diagnostic test: Risk stratification; advanced penicillin challenge after risk stratification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge	Negative predictive value of the risk stratification tool	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF; Helse Fonna; Helse Forde; Haraldsplass Deaconess Hospital
• Investigators: Study Chair: Torgeir Storaas, phd, RAAO vest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: implementation; clinical pathway; penicillin allergy; delabeling
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity
• Other Study ID Numbers: 199210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No