Clinical trial NCT05090527: Penicillin Allergy Delabeling Project
Official title: Penicillin Delabeling With Help of a Risk Stratification Tool, Advanced Provocation Tests in a Non Allergologic Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Penicillin Allergy
Keywords: penicillin allergy
clinical pathway
implementation
delabeling
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Fonna
name: Helse Forde
name: Haraldsplass Deaconess Hospital
name: Helse Stavanger HF
First posted: 2021-10-22
Enrollment: 153
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Entry criteria: Penicillin allergy noted in patients journal or patient reported.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: Inclusion Criteria:

* Penicillin allergy in the patient journal oder patient reported

Exclusion Criteria:

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

Primary outcomes:
measure: Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge
timeFrame: 24 months
Secondary outcomes:
measure: Number of patients with treatment related adverse events on oral provocation testing.
timeFrame: 24 months
measure: Number of patients correctly delabeled
timeFrame: 24 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Førde
country: Norway
facility: Helse Førde
Study officials:
affiliation: RAAO vest
name: Torgeir Storaas, phd
role: STUDY_CHAIR
References:
citation: 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.