Status:
UNKNOWN
Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients
Lead Sponsor:
Saskatchewan Health Authority - Regina Area
Conditions:
Penicillin Allergy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 the...
Detailed Description
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, only \<5%-10% of them h...
Eligibility Criteria
Inclusion
- Assessed to be low risk of having a penicillin allergy as per the risk stratification questionnaire
- 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
- Age 18 years or older
- Hemodynamically stable and suitable for discharge home
Exclusion
- Declines participation in the study
- Cognitive impairment and where a collateral history could not be obtained
- History of anaphylaxis or angioedema attributed to a penicillin-based antibiotic
- History of severe cutaneous adverse reactions attributed to a penicillin-based antibiotic
- History of acute kidney injury or severe liver impairment attributed to a penicillin-based antibiotic
- Currently taking an angiotensin-converting enzyme inhibitor, angiotensin-receptor blocker or a beta blocker
- Hemodynamically unstable
- History of idiopathic urticaria or idiopathic anaphylaxis
- Currently taking an antibiotic(s) for treatment of an active infection
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04408508
Start Date
December 1 2023
End Date
June 1 2024
Last Update
April 13 2023
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