Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients

REB-19-97

Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of the population and 20% of inpatients carry a label of penicillin allergy. However, less than 5%-10% of them have a confirmed allergy following comprehensive investigations. Reported penicillin allergy leads to higher medical costs and excess complications and presents a major challenge to antimicrobial stewardship. There is a high demand for allergy services however penicillin allergy testing (including skin testing and oral drug challenge) is not routinely available for inpatients even in major centres. Direct oral amoxicillin challenges are safe and effective in delabeling low risk patients who report penicillin allergy in large paediatric and adult studies and does not necessitate specialist referral. The study team seeks to determine the safety and efficacy of a single-dose oral penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). The study investigators will determine the number of patients successfully delabelled of their "penicillin allergy" prior to discharge from hospital over a 12 month period. The study doctors will also assess the economic impact of the investigator's model and ease of implementation in the busy inpatient setting. In the future this model could be implemented generally as an inpatient or outpatient penicillin allergy program where low risk patients, who do not require referral to an allergist, are expeditiously delabelled.

2023-12-01

2024-03-01

2024-06-01

Not yet recruiting

50

Inclusion Criteria: 1. Assessed to be low risk of having a penicillin allergy as per the risk stratification questionnaire 2. One of the following: i) An unknown reaction \>10 years before, ii) A type A adverse drug reaction (pharmacologically predictable drug side effect or intolerance), or iii) A history of a benign childhood rash, nonurticarial rash, or maculopapular exanthem more than 10 years ago 3. Age 18 years or older 4. Hemodynamically stable and suitable for discharge home Exclusion Criteria: 1. Declines participation in the study 2. Cognitive impairment and where a collateral history could not be obtained 3. History of anaphylaxis or angioedema attributed to a penicillin-based antibiotic 4. History of severe cutaneous adverse reactions attributed to a penicillin-based antibiotic 5. History of acute kidney injury or severe liver impairment attributed to a penicillin-based antibiotic 6. Currently taking an angiotensin-converting enzyme inhibitor, angiotensin-receptor blocker or a beta blocker 7. Hemodynamically unstable 8. History of idiopathic urticaria or idiopathic anaphylaxis 9. Currently taking an antibiotic(s) for treatment of an active infection

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients reporting penicillin allergy will be enrolled based on eligibility criteria for direct oral amoxicillin challenge. There will be one treatment group of patients assigned low risk for penicillin allergy.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-04-13