Back to resultsDe-labeling of Patients With False Diagnosis of Penicillin Allergy
Primary Purpose
Allergy Drug
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Allergy work-up
Blood samples and microbiological samples.
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergy Drug focused on measuring Penicillin/b-lactams
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Cardiac disease with increased risk of serious anaphylaxis
- Pregnancy/Breastfeeding
- Reaction within the last 4-6 weeks
Sites / Locations
- Oslo University Hospital, Dpt of Pulmonary Diseases, UllevålRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients labeled as penicillin allergic
Healthy Controls
Arm Description
Patients labeled as penicillin allergic will be allergologically investigated to confirm/exclude the diagnosis. Allergy work-up will be performed. Blood samples and Microbiological samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention.
Healthy Controls, blood samples and microbiological samples.Clinical history
Outcomes
Primary Outcome Measures
Prevalence of Penicillin allergy in the studied group
Frequency of true penicillin allergy in the study group
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.
Secondary Outcome Measures
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?"
Prevalence of multidrug resistant bacteria and use of broad spectrum antibiotics in patients labeled as penicillin allergic
Prevalence of multidrug resistant bacteria by bacterial culture from nostriles. Register the use of broad spectrum antibiotics in patients that have been treated with antibiotics prior to allergy work-up.
Immune phenotype of penicillin allergic patients by determination of cytokine/chemokine levels.
Measurement of cytokine/chemokine levels in blood samples.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03581604
Brief Title
De-labeling of Patients With False Diagnosis of Penicillin Allergy
Official Title
Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy Drug
Keywords
Penicillin/b-lactams
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient group consisting of patients labeled as penicillin allergic and a controll group of healthy volunteers
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients labeled as penicillin allergic
Arm Type
Other
Arm Description
Patients labeled as penicillin allergic will be allergologically investigated to confirm/exclude the diagnosis. Allergy work-up will be performed. Blood samples and Microbiological samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention.
Arm Title
Healthy Controls
Arm Type
Other
Arm Description
Healthy Controls, blood samples and microbiological samples.Clinical history
Intervention Type
Diagnostic Test
Intervention Name(s)
Allergy work-up
Intervention Description
Allergy work-up
Intervention Type
Other
Intervention Name(s)
Blood samples and microbiological samples.
Intervention Description
Blood samples and microbiological samples
Primary Outcome Measure Information:
Title
Prevalence of Penicillin allergy in the studied group
Description
Frequency of true penicillin allergy in the study group
Time Frame
up to 4 years
Title
Negative predictive value of the allergy work- up
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.
Description
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?"
Time Frame
12 months
Title
Prevalence of multidrug resistant bacteria and use of broad spectrum antibiotics in patients labeled as penicillin allergic
Description
Prevalence of multidrug resistant bacteria by bacterial culture from nostriles. Register the use of broad spectrum antibiotics in patients that have been treated with antibiotics prior to allergy work-up.
Time Frame
up to 4 years
Title
Immune phenotype of penicillin allergic patients by determination of cytokine/chemokine levels.
Description
Measurement of cytokine/chemokine levels in blood samples.
Time Frame
up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Cardiac disease with increased risk of serious anaphylaxis
Pregnancy/Breastfeeding
Reaction within the last 4-6 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Stylianou, Phd
Phone
004722118784
Email
eva.stylianou@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Stylianou, Phd
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål
City
Oslo
State/Province
Postbox 4950 Nydalen
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Stylianou, PHD
Phone
004722118784
Email
eva.stylianou@ous-hf.no
12. IPD Sharing Statement
Learn more about this trial
De-labeling of Patients With False Diagnosis of Penicillin Allergy
We'll reach out to this number within 24 hrs