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Penicillin Allergy Delabeling Project

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05090527
Acronym
PenProv
Enrollment
153
Registered
2021-10-22
Start date
2021-07-28
Completion date
2023-05-01
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penicillin Allergy

Keywords

penicillin allergy, clinical pathway, implementation, delabeling

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

Interventions

DIAGNOSTIC_TESTRisk stratification

advanced penicillin challenge after risk stratification

Sponsors

Helse Fonna
CollaboratorOTHER
Helse Forde
CollaboratorOTHER
Haraldsplass Deaconess Hospital
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

None, open provocation test with amoxicillin for eligible patients after risk stratification with a questionnaire.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Penicillin allergy in the patient journal oder patient reported

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge24 monthsNegative predictive value of the risk stratification tool

Secondary

MeasureTime frameDescription
Number of patients with treatment related adverse events on oral provocation testing.24 monthsnumber of patients with treatment related adverse event on oral provocation testing.
Number of patients correctly delabeled24 monthsOg the patientents included in the implementation in clinical practice, how many had a correct procedure and result.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026