World-first clinical trial to help millions with penicillin allergies JAMAInternalMed
Is direct oral penicillin challenge in adults with a low-risk penicillin allergy, defined as a PEN-FAST score less than 3, safe and effective compared with the standard-of-care penicillin skin testing followed by an oral penicillin challenge?In this randomized clinical trial of 382 patients across 6 centers in 3 countries, a positive penicillin oral challenge consistent with an immune-mediated reaction occurred in 0.
This parallel, 2-arm, noninferiority, open-label, multicenter, international randomized clinical trial occurred in 6 specialized centers, 3 in North America and 3 in Australia, from June 18, 2021, to December 2, 2022. Eligible adults had a PEN-FAST score lower than 3. PEN-FAST is a prospectively derived and internationally validated clinical decision rule that enables point-of-care risk assessment for adults reporting penicillin allergies.
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