De-labeling of Patients With False Diagnosis of Penicillin Allergy

NCT03581604 | Recruiting

• 1 other identifier: 2017/2119/REK
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy Drug

Keywords

Penicillin/b-lactams

Outcome Measures

Primary Outcomes (2)

• Prevalence of Penicillin allergy in the studied group

  Frequency of true penicillin allergy in the study group

  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.

  3 weeks

Secondary Outcomes (1)

• Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.

  12 months

Study Arms (1)

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.

Diagnostic Test: Allergy work-up; Other: Blood samples

Interventions

Allergy work-up DIAGNOSTIC_TEST

Allergy work-up

Patients labeled as penicillin allergic

Blood samples OTHER

Blood samples

Patients labeled as penicillin allergic

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål

Oslo, Postbox 4950 Nydalen, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Drug Hypersensitivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eva Stylianou, Phd

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Stylianou, Phd

CONTACT

004722118784; eva.stylianou@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patient group consisting of patients labeled as penicillin allergic.

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: July 10, 2018
• Study Start: September 13, 2017
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

NO (1)