Penicillin AllergyPenProvNCT05090527
Penicillin Allergy Delabeling Project
A study testing Risk stratification in people with Penicillin Allergy, run by Haukeland University Hospital at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Risk stratification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesNorway
- Study dates
- 28 Jul 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Penicillin allergy in the patient journal oder patient reported
Who cannot join
- Not able to give concent. Under 16 years of age.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Penicillin Delabeling With Help of a Risk Stratification Tool, Advanced Provocation Tests in a Non Allergologic Unit
A investigational study to establish:
- A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments.
- A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling.
- A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians.
- Implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the Western Norway health region.
Read the 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
- Conditions
- Penicillin Allergy
- Being tested
- Risk stratification
- Keywords
- penicillin allergy, clinical pathway, implementation, delabeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk stratificationDiagnostic test
advanced penicillin challenge after risk stratification
| Study group | Role | What they receive |
|---|---|---|
| Directly delabeled trough risk stratification tool | Active comparator | Patients who are stratified as " no penicillin allergy" undergo a one dose full dose provocation test with 500 mg amoxicillin. Receives: Diagnostic Test: Risk stratification |
| Low risk patients | Active comparator | Patients stratified as low risk on penicillin provocation undergo a one dose full dose provocation test with 500mg amoxicillin Receives: Diagnostic Test: Risk stratification |
| High risk | Active comparator | Patient stratified as high risk undergo a full allergologic work up, and only some of these will undergo a provocation test. Receives: Diagnostic Test: Risk stratification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge
Negative predictive value of the risk stratification tool
Measured: 24 months
Secondary outcomes (2)
Number of patients with treatment related adverse events on oral provocation testing.
number of patients with treatment related adverse event on oral provocation testing.
Measured: 24 months
Number of patients correctly delabeled
Og the patientents included in the implementation in clinical practice, how many had a correct procedure and result.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start28 Jul 2021
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Penicillin AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Entry criteria: Penicillin allergy noted in patients journal or patient reported.
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Fonna, Helse Forde, Haraldsplass Deaconess Hospital, Helse Stavanger HF
- Responsible party
- Sponsor
- Investigators
- Torgeir Storaas, phd, Study chair, RAAO vest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090527
- Sponsor's protocol ID
- 199210
- Acronym
- PenProv
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37868111
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penicillin Delabeling With Help of a Risk Stratification Tool, Advanced Provocation Tests in a Non Allergologic Unit
- ClinicalTrials.gov ID
- NCT05090527
- Acronym / sponsor ID
- PenProv / 199210
- Conditions
- Penicillin Allergy
- Keywords
- penicillin allergy, clinical pathway, implementation, delabeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Fonna, Helse Forde, Haraldsplass Deaconess Hospital, Helse Stavanger HF
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A investigational study to establish:
- A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments.
- A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling.
- A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians.
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Entry criteria: Penicillin allergy noted in patients journal or patient reported.
| Arm | Type | Receives |
|---|---|---|
| Directly delabeled trough risk stratification tool | Active comparator | Diagnostic Test: Risk stratificationPatients who are stratified as " no penicillin allergy" undergo a one dose full dose provocation test with 500 mg amoxicillin. |
| Low risk patients | Active comparator | Diagnostic Test: Risk stratificationPatients stratified as low risk on penicillin provocation undergo a one dose full dose provocation test with 500mg amoxicillin |
| High risk | Active comparator | Diagnostic Test: Risk stratificationPatient stratified as high risk undergo a full allergologic work up, and only some of these will undergo a provocation test. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Penicillin allergy in the patient journal oder patient reported
Key exclusion criteria (1 listed)
- Not able to give concent. Under 16 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk stratificationadvanced penicillin challenge after risk stratification | Diagnostic test | Directly delabeled trough risk stratification tool, High risk, Low risk patients |
Primary outcome
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
2 secondary outcomes
Number of patients with treatment related adverse events on oral provocation testing.
Time frame: 24 months
Number of patients correctly delabeled
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Results publication: PubMed 37868111Alnaes 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.
- Individual participant dataSharing planned: No
Related trials for Penicillin Allergy
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
RecruitingPhase 2
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
Drug Allergy, Cephalosporin Allergy
RecruitingPhase 4
Allergy Delabeling in Antibiotic Stewardship - Intervention
Beta Lactam Allergy, Hematologic Malignancy
Enrolling by invitationObservational study
Allergy Delabeling in Antibiotic Stewardship - Evaluations
Beta Lactam Allergy in Patients With a Hematologic Malignancy
RecruitingObservational study
Provocation After Nurse-Directed Assessment (PANDA) Study
Drug Allergy, Penicillin Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torgeir Storaas, phd study chair
RAAO vest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk stratification in people with Penicillin Allergy, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05090527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.