Allergy DrugNCT03581604
De-labeling of Patients With False Diagnosis of Penicillin Allergy
A study testing Allergy work-up and Blood samples in people with Allergy Drug, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy Drug
- What is being tested?
- Allergy work-up and Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteNorway
- Study dates
- 13 Sep 2017to 4 Dec 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients who are referred to the department of Pulmonary medicine with clinical history suspected of having penicillin allergy.
- The control group will be healthy adult volunteers with no history of any personal or family history of drug allergy, atopy, inflammatory or autoimmune diseases.
Who cannot join
- Systemic reactions such as DRESS, any internal organ involvement
- Clinical history of Type II-III hypersensitivity reaction
- Severe Type IV hypersensitivity reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, vasculitis, acute generalized exanthematous pustulosis
- Chronic idiopathic urticaria on antihistamine maintenance treatment/anti-IgE treatment
- Medication which can affect the test outcome
- Active signs of an underlying disease such as uncontrolled asthma
Show all 9Show fewer
- Cardiac disease with increased risk of serious anaphylaxis
- Pregnancy/Breastfeeding
- Reaction within the last 4-6 weeks
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål
Oslo, Postbox 4950 Nydalen, 0424
About this study
Official title: Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance
The purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy.
Read the detailed description
Penicillin allergy is the most common of self-reported drug allergies and un-verified penicillin allergy is a significant and growing public health problem. 10% of all patients report penicillin allergy. However, there is large discrepancy between reported penicillin allergy and true allergy. Despite its high prevalence, greater than 90% of such patients are in fact able to tolerate the medication without allergic reactions.
In this study patients having a penicillin allergy label will be investigated to confirm or to exclude the allergy diagnosis. The diagnostic value of the allergen test panel and the allergologic work-up will be evaluated. Clinical parameters as well as immunological will be assessed.
- Conditions
- Allergy Drug
- Being tested
- Allergy work-up, Blood samples
- Keywords
- Penicillin/b-lactams
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergy work-upDiagnostic test
Allergy work-up
Blood samplesOther
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Patients labeled as penicillin allergic | Other | Patients labeled as penicillin allergic will be allergologically investigated to confirm/exclude the diagnosis. Allergy work-up will be performed. Blood samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention. Receives: Diagnostic Test: Allergy work-up; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Penicillin allergy in the studied group
Frequency of true penicillin allergy in the study group
Measured: up to 4 years
Negative predictive value of the allergy work- up
If the allergy work-up is negative, drug provocation test with penicillin will be performed. The purpose of the drug challenge is to confirm lack of allergy and confirm the negative predictive value of the allergy work-up.
Measured: 3 weeks
Secondary outcomes (1)
Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.
Patients going through an allergy workup with negative results, will be retrospectively contacted within one year after investigation. Telephone interview where the following questions will be asked:1) "Have you received antibiotic therapy since being seen in the allergy clinic?" 2) "If you have been treated, what drug did you take?" 3) "As a result of this, did you have a reaction to the antibiotics?" "If yes, what kind of reaction have you developed?" 4) "If you didn't take the drug you were challenged with what was the reason for that?"
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start13 Sep 2017
- Primary completion11 Aug 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy DrugStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient group consisting of patients labeled as penicillin allergic.
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Stylianou, Oslo University Hospital
- Investigators
- Eva Stylianou, Phd, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581604
- Sponsor's protocol ID
- 2017/2119/REK
- Status last verified
- Nov 2023
- First submitted
- 4 May 2018
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance
- ClinicalTrials.gov ID
- NCT03581604
- Acronym / sponsor ID
- 2017/2119/REK
- Conditions
- Allergy Drug
- Keywords
- Penicillin/b-lactams
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 10 Jul 2018 (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.
The purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy.
Detailed description
Penicillin allergy is the most common of self-reported drug allergies and un-verified penicillin allergy is a significant and growing public health problem. 10% of all patients report penicillin allergy. However, there is large discrepancy between reported penicillin allergy and true allergy. Despite its high prevalence, greater than 90% of such patients are in fact able to tolerate the medication without allergic reactions.
In this study patients having a penicillin allergy label will be investigated to confirm or to exclude the allergy diagnosis. The diagnostic value of the allergen test panel and the allergologic work-up will be evaluated. Clinical parameters as well as immunological will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient group consisting of patients labeled as penicillin allergic.
| Arm | Type | Receives |
|---|---|---|
| Patients labeled as penicillin allergic | Other | Diagnostic Test: Allergy work-up, Other: Blood samplesPatients labeled as penicillin allergic will be allergologically investigated to confirm/exclude the diagnosis. Allergy work-up will be performed. Blood samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who are referred to the department of Pulmonary medicine with clinical history suspected of having penicillin allergy.
- The control group will be healthy adult volunteers with no history of any personal or family history of drug allergy, atopy, inflammatory or autoimmune diseases.
Key exclusion criteria (9 listed)
- Systemic reactions such as DRESS, any internal organ involvement
- Clinical history of Type II-III hypersensitivity reaction
- Severe Type IV hypersensitivity reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, vasculitis, acute generalized exanthematous pustulosis
- Chronic idiopathic urticaria on antihistamine maintenance treatment/anti-IgE treatment
- Medication which can affect the test outcome
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 |
|---|---|---|
| Allergy work-upAllergy work-up | Diagnostic test | Patients labeled as penicillin allergic |
| Blood samplesBlood samples | Other | Patients labeled as penicillin allergic |
Primary outcome
Prevalence of Penicillin allergy in the studied group
Time frame: up to 4 years
Frequency of true penicillin allergy in the study group
Negative predictive value of the allergy work- up
Time frame: 3 weeks
If the allergy work-up is negative, drug provocation test with penicillin will be performed. The purpose of the drug challenge is to confirm lack of allergy and confirm the negative predictive value of the allergy work-up.
1 secondary outcome
Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.
Time frame: 12 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 26 May 2026.
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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.
Eva Stylianou, Phd principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergy work-up and Blood samples in people with Allergy Drug, run by Oslo University Hospital at 1 site 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 2 inclusion and 9 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of Penicillin allergy in the studied group (time frame: up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.