Penicillin Allergy Delabeling Project
- Conditions
- Penicillin Allergy
- Interventions
- Diagnostic Test: Risk stratification
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- Penicillin allergy in the patient journal oder patient reported
- Not able to give concent. Under 16 years of age.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Directly delabeled trough risk stratification tool Risk stratification Patients who are stratified as " no penicillin allergy" undergo a one dose full dose provocation test with 500 mg amoxicillin. Low risk patients Risk stratification Patients stratified as low risk on penicillin provocation undergo a one dose full dose provocation test with 500mg amoxicillin High risk Risk stratification Patient stratified as high risk undergo a full allergologic work up, and only some of these will undergo a provocation test.
- 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)
Helse Førde
🇳🇴Førde, Norway
Haukeland University Hospital
🇳🇴Bergen, Norway