Penicillin Allergy Delabeling Project

Penicillin Allergy Clinical Trial

— PenProv  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090527
• Other study ID #: 199210
• Status: Completed
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Penicillin allergy in the patient journal oder patient reported

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity
• Penicillin Allergy

Intervention

Diagnostic Test:
• Risk stratification
advanced penicillin challenge after risk stratification

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Helse Førde	Førde

Sponsors (5)

Lead Sponsor	Collaborator
Haukeland University Hospital	Haraldsplass Deaconess Hospital, Helse Fonna, Helse Forde, Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge	Negative predictive value of the risk stratification tool	24 months
Secondary	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
Secondary	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