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Completed

NCT Number: NCT05090527

Penicillin Allergy Delabeling Project

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.

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Key information

Conditions

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Penicillin allergy in the patient journal oder patient reported

Exclusion criteria

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

Treatment and study plan

Risk stratification

Diagnostic Test

advanced penicillin challenge after risk stratification

Primary outcomes

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

    Time frame: 24 months

    Negative predictive value of the risk stratification tool

Secondary outcomes

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

    Time frame: 24 months

    number of patients with treatment related adverse event on oral provocation testing.

  2. Number of patients correctly delabeled

    Time frame: 24 months

    Og the patientents included in the implementation in clinical practice, how many had a correct procedure and result.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Haraldsplass Deaconess Hospital
  • Helse Fonna
  • Helse Forde
  • Helse Stavanger HF

Registry information

Official study title

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

Acronym: PenProv

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2021
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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