Establishing Amoxicillin Allergy in Children Through Direct Graded Oral Challenge (GOC): Evaluating Risk Factors for Positive Challenges, Safety, and Risk of Cross-Reactivity to Cephalosporines

Exius, Rutherford; Gabrielli, Sofianne; Abrams, Elissa M.; O’Keefe, Andrew; Protudjer, Jennifer L. P.; Lavine, Elana; Pitt, Tracy; Atkinson, Adelle; Eiwegger, Thomas; McCusker, Christine; Ben‐Shoshan, Moshe

doi:10.1016/j.jaip.2021.06.057

Cited by 35 publications

(27 citation statements)

References 31 publications

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“…In that paper 42 out of 1914 (2.2%) children had a mild immediate reaction (IR) to DPT, with 3 of these patients (7%) reacting to the first dose of the DPT, however, it should be taken into account that the children included in the study were also those with history of IR. 4 In terms of number of patients, prevalence of positive DPT and timing of reactions, our results are very similar to the recent paper of Petersen et al 17 where the incidence of positive DPT was 6.7% (22/305), and none of the children reacted on the first 1/10 of the full dose.…”

Section: Re Sultssupporting

confidence: 91%

“…This multicentric study shows the safety of skipping the intradermal test by performing a graded oral DPT directly, even if the duration of the DPT is not reported. In that paper 42 out of 1914 (2.2%) children had a mild immediate reaction (IR) to DPT, with 3 of these patients (7%) reacting to the first dose of the DPT, however, it should be taken into account that the children included in the study were also those with history of IR 4 …”

Section: Discussionmentioning

confidence: 99%

“…Despite the widely demonstrated safety of performing a direct DPT without previous skin testing in mild NIR to βLs, to date, there are many controversies about the best protocol that should be used for the DPT (which remains the gold standard for the diagnosis), especially regarding the number of doses to be administrated and the length of the DPT itself 3–7 …”

Section: Introductionmentioning

confidence: 99%

“…1,2 Despite the widely demonstrated safety of performing a direct DPT without previous skin testing in mild NIR to βLs, to date, there are many controversies about the best protocol that should be used for the DPT (which remains the gold standard for the diagnosis), especially regarding the number of doses to be administrated and the length of the DPT itself. [3][4][5][6][7] Several studies report the results of a single day versus a prolonged DPT in terms of sensitivity and negative predictive value (NPV). Indeed, the most recent papers seem to demonstrate a slightly higher diagnostic sensitivity of the extended protocols.…”

Section: Introductionmentioning

confidence: 99%

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Simplifying the drug provocation test in non‐immediate hypersensitivity reactions to amoxicillin in children: The experience of a tertiary care allergy unit

Liccioli

Giovannini

Caubet

et al. 2022

Pediatric Allergy Immunology

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Background: Mild non-immediate reactions (NIR) to beta-lactams (βLs) are the most common manifestation of adverse drug reactions in children, and the drug provocation test (DPT) remains the gold standard for diagnosis. However, there are still controversies about the protocol that should be used, especially regarding the administration of doses and the DPT length.Objective: This study aimed to evaluate a pediatric population with a history of mild NIR to amoxicillin (AMX) or to amoxicillin-clavulanic acid (AMX/CL) who underwent a diagnostic workup including a DPT with the culprit drug, to understand if a graded DPT or, instead, a single full dose could be the most appropriate way of administration in clinical practice. Methods:The data of children were retrospectively analyzed for a 5-year period, with demographic and clinical characteristics collected. We reported the allergy workup and the results of the DPT performed with the administration of incremental doses and a prolonged DPT at home for a total of 5 days.Results: Three hundred fifty-four patients were included. Overall, 23/354 (6.5%) DPTs were positive: 11/23 patients showed a reaction after 2-8 h after the last dose on the 1st or 2nd day (1 reacted 30 min after the last dose), 1/23 reacted with urticaria 30 min after the first dose, 11/23 reacted at home on the 5th day of the DPT. Conclusion:This paper indirectly suggests that a single therapeutic dose administered on the 1st day of a DPT could be safe in the diagnostic workup of mild NIR to AMX/CL. Moreover, this could be less time-consuming as patients would spend less time in the hospital, also considering the public health restrictions imposed during the COVID-19 pandemic.

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Section: Re Sultssupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Simplifying the drug provocation test in non‐immediate hypersensitivity reactions to amoxicillin in children: The experience of a tertiary care allergy unit

Liccioli

Giovannini

Caubet

et al. 2022

Pediatric Allergy Immunology

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“…2 Following direct oral penicillin challenge, 94.6% of such labels are removed. 3,4 However, despite published algorithms, 5 there are no validated pediatric decision rules to guide clinician management. The aim of this cohort study was to examine the previously validated PEN-FAST adult score 6 in children.…”

mentioning

confidence: 99%

Validation of the PEN-FAST Score in a Pediatric Population

et al. 2022

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Reaction Risk to Direct Penicillin Challenges

Blumenthal,

Smith,

Mann

et al. 2024

JAMA Intern Med

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ImportanceWhile direct penicillin challenges might support the expansion of penicillin allergy delabeling efforts, the perceived risk of reactions remains a key barrier.ObjectiveTo evaluate the frequency of reactions to direct penicillin challenges in individuals with penicillin allergy labels and to identify factors associated with such reactions.Data SourcesThree electronic databases were searched (MEDLINE, Web of Science, and Scopus) from inception to July 19, 2023, for primary studies assessing patients undergoing direct penicillin challenges. Articles were included regardless of publication year, language, status, or definition of allergy risk.Study SelectionTwo reviewers independently selected original studies reporting the frequency of immunologically mediated reactions following a direct penicillin challenge in patients reporting a penicillin allergy.Data Extraction and SynthesisTwo reviewers independently extracted data and independently assessed the quality of each primary study using a risk-of-bias tool for prevalence studies.Main Outcomes and MeasuresThe primary outcome was the frequency of reactions to direct penicillin challenges as calculated using random-effects bayesian meta-analysis of proportions. Secondary outcomes included risk factors for reactions and the frequency of severe reactions.ResultsA total of 56 primary studies involving 9225 participants were included. Among participants, 438 experienced reactions to direct penicillin challenges without prior testing, corresponding to an overall meta-analytic frequency of 3.5% (95% credible interval [CrI], 2.5%-4.6%). Meta-regression analyses revealed that studies performed in North America had lower rates of reaction to direct challenges (odds ratio [OR], 0.36; 95% CrI, 0.20-0.61), while studies performed in children (OR, 3.37; 95% CrI, 1.98-5.98), in outpatients (OR, 2.19; 95% CrI, 1.08-4.75), and with a graded (OR, 3.24; 95% CrI, 1.50-7.06) or prolonged (OR, 5.45; 95% CrI, 2.38-13.28) challenge had higher rates of reaction. Only 5 severe reactions (3 anaphylaxis, 1 fever with rash, and 1 acute kidney injury) were reported, none of which were fatal.Conclusions and RelevanceThis systematic review and meta-analysis found that reactions to direct penicillin challenges are infrequent, with rates comparable to indirect challenges after allergy testing. These findings suggest that direct challenges are safe for incorporation into penicillin allergy evaluation efforts across age groups and clinical settings.

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Establishing Amoxicillin Allergy in Children Through Direct Graded Oral Challenge (GOC): Evaluating Risk Factors for Positive Challenges, Safety, and Risk of Cross-Reactivity to Cephalosporines

Cited by 35 publications

References 31 publications

Simplifying the drug provocation test in non‐immediate hypersensitivity reactions to amoxicillin in children: The experience of a tertiary care allergy unit

Simplifying the drug provocation test in non‐immediate hypersensitivity reactions to amoxicillin in children: The experience of a tertiary care allergy unit

Validation of the PEN-FAST Score in a Pediatric Population

Reaction Risk to Direct Penicillin Challenges

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