Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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 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.