Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

NCT06755281 | Recruiting

• 1 other identifier: S-656/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this clinical trial is to analyze the negative predictive capacity and safety of risk-stratified direct drug provocation tests for patients with self-reported penicillin allergies. Patients reporting immediate or delayed penicillin allergies and defined as low-risk by the PEN-FAST score will receive drug provocation tests without prior skin testing.

Conditions

Penicillin Allergy; Hypersensitivity, Immediate; Hypersensitivity, Delayed; Hypersensitivity Response

Keywords

PEN-FAST; penicillin allergy; allergy delabeling

Outcome Measures

Primary Outcomes (1)

• The difference in the proportion of patients with any positive finding in skin tests, allergen-specific IgE or drug provocation test between the two groups

  Percentage of subjects that retain their allergy label as they show at least one positive finding in skin tests, allergen-specific IgE or drug provocation test.

  7 days

Secondary Outcomes (11)

• Negative predictive capacity of skin tests and allergen-specific IgE

  7 days

• Analysis of medical and allergic history

  1 day

• Penicillin allergy label

  1 day

• Analysis of demographic data

  1 day

• Analysis of adverse reactions

  7 days

Study Arms (2)

Direct drug provocation test

EXPERIMENTAL

Other: Direct Oral challenge

Standard of care

ACTIVE COMPARATOR

Standard of care Skin testing and measurement of allergen-specific IgE, if negative, drug provocation test.

Other: standard of care

Interventions

Direct Oral challenge OTHER

Patients will receive a 1-step or 2-step challenge with the suspected penicillin and will be monitored for any allergic reaction within the first four hours. Patients will be instructed to contact the hospital after the drug provocation test to inquire delayed allergic reactions.

Direct drug provocation test

standard of care OTHER

The patient will receive skin prick test and patch test (if a delayed allergy is suspected). Allergen-specific IgE will be measured. If all negative, drug provocation tets will be performed identical to the experimental group.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult outpatients or inpatients with a penicillin allergy label
• Willing and able to give consent.
• PEN-FAST score of 0-2 points

You may not qualify if:

• Age \<18 years
• Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent
• Concurrent antihistamine therapy
• Pregnancy
• Significantly impaired general condition
• Unstable or therapeutically inadequately controlled bronchial asthma
• History of stem cell transplantation
• History of acute interstitial nephritis
• Chronic urticaria
• Mastocytosis

Sponsors & Collaborators

• Deniz Göcebe: lead

Study Sites (2)

University Hospital Heidelberg, Dermatology

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (2)

• Copaescu AM, Vogrin S, James F, Chua KYL, Rose MT, De Luca J, Waldron J, Awad A, Godsell J, Mitri E, Lambros B, Douglas A, Youcef Khoudja R, Isabwe GAC, Genest G, Fein M, Radojicic C, Collier A, Lugar P, Stone C, Ben-Shoshan M, Turner NA, Holmes NE, Phillips EJ, Trubiano JA. Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy: The PALACE Randomized Clinical Trial. JAMA Intern Med. 2023 Sep 1;183(9):944-952. doi: 10.1001/jamainternmed.2023.2986.

  PMID: 37459086 BACKGROUND

• Trubiano JA, Vogrin S, Chua KYL, Bourke J, Yun J, Douglas A, Stone CA, Yu R, Groenendijk L, Holmes NE, Phillips EJ. Development and Validation of a Penicillin Allergy Clinical Decision Rule. JAMA Intern Med. 2020 May 1;180(5):745-752. doi: 10.1001/jamainternmed.2020.0403.

  PMID: 32176248 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity, Delayed

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Deniz Göcebe, MD

CONTACT

+4962215639539; Deniz.Goecebe@med.uni-heidelberg.de

Knut Schäkel, MD

CONTACT

Knut.Schaekel@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Deniz Göcebe

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 1, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who offer a well-structured and scientifically sound approach to realizing the objectives detailed in the approved proposal.

Locations

DE (2)