Penicillin Allergy Delabeling Project

NCT05090527 | Completed

• 1 other identifier: 199210
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

Brief Summary

A investigational study to establish:

1. 1.A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments.
2. 2.A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling.
3. 3.A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians.

Conditions

Penicillin Allergy

Keywords

penicillin allergy; clinical pathway; implementation; delabeling

Outcome Measures

Primary Outcomes (1)

• Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge

  Negative predictive value of the risk stratification tool

  24 months

Secondary Outcomes (2)

• Number of patients with treatment related adverse events on oral provocation testing.

  24 months

• Number of patients correctly delabeled

  24 months

Study Arms (3)

Directly delabeled trough risk stratification tool

ACTIVE COMPARATOR

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

Diagnostic Test: Risk stratification

Low risk patients

ACTIVE COMPARATOR

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

Diagnostic Test: Risk stratification

High risk

ACTIVE COMPARATOR

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

Interventions

Risk stratification DIAGNOSTIC_TEST

advanced penicillin challenge after risk stratification

Directly delabeled trough risk stratification tool; High risk; Low risk patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Penicillin allergy in the patient journal oder patient reported

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Fonna: collaborator
• Helse Forde: collaborator
• Haraldsplass Deaconess Hospital: collaborator
• Helse Stavanger HF: collaborator

Study Sites (2)

Haukeland University Hospital

Bergen, Norway

Location

Helse Førde

Førde, Norway

Location

Related Publications (1)

• 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.

  PMID: 37868111 RESULT

Study Officials

• Torgeir Storaas, phd

  RAAO vest

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None, open provocation test with amoxicillin for eligible patients after risk stratification with a questionnaire.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Entry criteria: Penicillin allergy noted in patients journal or patient reported.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: October 22, 2021
• Study Start: July 28, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 9, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)