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Penicillin allergy affects more than 25 million people in the United States (up to 1 in 10 Americans) and has been shown to lead to particularly poor health outcomes in pregnant women and surgical patients. It is also a threat to public health, leading to antibiotic resistance and potentially life-threatening infections in hospitalized patients.
75% or more of penicillin allergy labels appear by age 3 due to, for example, confusion with a viral rash. Most of these rashes were never allergic, but the tags do ‘stick’ in adulthood and carry many adverse consequences.”
Many low-risk patients with penicillin allergy were able to have the penicillin allergy label removed through a simple procedure known as “direct oral challenge” as part of a first multicenter randomized control trial known as Decision Rule Penicillin Allergy Clinic (PALACE) study.
In the PALACE study, researchers randomly assigned low-risk penicillin-allergic patients to two different approaches to removing the allergy label. They either underwent the current standard of care of skin testing followed by an oral challenge with penicillin if negative, or went directly to oral challenge (‘direct oral challenge’) without prior skin testing.
“Most of the patients labeled penicillin-allergic, more than 90%, have a low-risk history, meaning they had no history to suggest a more recent or severe reaction to penicillin,” said the protocol member of the PALACE Study and Vanderbilt University Physician. The center’s principal investigator, Elizabeth Phillips, MD, John Oates Professor of Clinical Research. “We would expect more than 95% of these patients to have negative results and be able to take penicillin in the future.”
The study, conducted by a team of researchers from specialized centers in North America and Australia, enrolled 382 adults who were assessed using a specialized risk assessment tool called PEN-FAST. Participants were randomized to receive either a direct oral penicillin challenge or the standard approach (penicillin skin test followed by an oral challenge). The primary objective was to determine whether direct oral challenge with penicillin was no worse than the standard method of skin testing followed by oral challenge that must be performed in an allergist’s office.
Only one patient (0.5%) from each group experienced a positive reaction to penicillin challenge, demonstrating that direct oral penicillin challenge works as well as the standard method. Importantly, there were no significant differences in adverse events between the two groups, and no serious adverse events were reported.
The findings have broad implications for patients. By accurately identifying low-risk penicillin-allergic patients, healthcare providers can ensure appropriate antibiotic prescriptions. Patients with a documented penicillin allergy are more likely to be prescribed alternative antibiotics, known as second-line antibiotics, which are often not as effective against certain infections and may have more side effects.
“Patients with penicillin allergy are more likely to receive second-line or broader-spectrum antibiotics that carry a risk of antibiotic resistance and serious infections, such as antibiotic-associated diarrhea due to Clostridioides difficile, which can spread through hospitals and become a major public health problem. .” Phillips said. “In the US, increasingly, we also have a significant problem with other antibiotic-resistant ‘superbugs,’ including multidrug-resistant gram-negative infections, Candida auris, and even a resurgence of syphilis, for which penicillin is best. treatment and the only treatment that should be used during pregnancy to prevent transmission to the fetus.
“The evidence provided by the PALACE study will change clinical practice. Many patients in the United States do not have direct access to an allergist for specialized tests, such as skin tests. Thus, the ability to move to direct oral challenge with a penicillin in low-risk patients that can be performed in any observed setting will make it easier for patients in the United States to access medical care to safely and safely remove penicillin label effective. allergy,” she said.
Reference: Copaescu AM, Vogrin S, James F, et al. Efficacy of a clinical decision rule to allow direct oral challenge in patients with low-risk penicillin allergy: the PALACE randomized clinical trial. JAMA Intern Med. 2023. doi: 10.1001/jamainternmed.2023.2986
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