Oral challenge vs routine care to assess low-risk penicillin allergy in critically ill hospital patients (ORACLE): a pilot safety and feasibility randomised controlled trial
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Le résumé fourni par la source
PURPOSE: Critically ill patients are vulnerable to penicillin allergy labels that may be incorrect. The validity of skin testing in intensive care units (ICUs) is uncertain. Many penicillin allergy labels are low risk, and validated tools exist to identify those amenable to direct oral challenge. This pilot randomised controlled trial explored the feasibility, safety, and validity of direct enteral challenge for low-risk penicillin allergy labels in critical illness. METHODS: Consenting patients with a low-risk penicillin allergy label (PAL) (PEN-FAST risk assessment score < 3) in four ICUs (Melbourne, Australia) were randomised 1:1 to penicillin (250 mg amoxicillin or implicated penicillin) direct enteral challenge versus routine care (2-h post-randomisation observation for each arm). Repeat challenge was performed post -ICU in the intervention arm. Patients were reviewed at 24 h and 5 days after each challenge/observation. RESULTS: We screened 533 patients. 130 (24.4%) were eligible and 80/130 (61.5%) enrolled (age median 64.5 years (interquartile range, IQR 53.5, 74), PEN-FAST median 1 (IQR 0,1)), with 40 (50%) randomised to direct enteral challenge. A positive challenge rate of 2.5% was identified. No antibiotic-associated serious adverse events were identified. 32/40 (80%) received a repeat challenge (zero positive). Post-randomisation, 13 (32%) of the intervention arm and 4 (10%) of the control arm received penicillin (odds ratio, OR 4.33 [1.27, 14.78] p = 0.019). CONCLUSION: These findings support the safety, validity, and feasibility of direct enteral challenge for critically ill patients with PEN-FAST assessed low-risk penicillin allergy. The absence of false negative results was confirmed by subsequent negative repeat challenges. A relatively low recruitment to screened ratio suggests that more inclusive eligibility criteria and integration of allergy assessment into routine ICU processes are needed to optimise allergy delabelling in critical illness.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Oral challenge vs routine care to assess low-risk penicillin allergy in critically ill hospital patients (ORACLE): a pilot safety and feasibility randomised controlled trial
- Date Crossref
- 13/05/2024
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Peter MacCallum Cancer Centre pays non établi dans la noticeÉtablissement de santé
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Peter Doherty Institute pays non établi dans la noticeStructure de recherche
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Austin Health Data Analytics Research and Evaluation Centre pays non établi dans la noticeÉtablissement de santé
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The University of Melbourne Department of Infectious Diseases pays non établi dans la noticeUniversité ou école supérieure
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Austin Hospital Department of Intensive Care pays non établi dans la noticeÉtablissement de santé
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St Vincent's Hospital Melbourne pays non établi dans la noticeÉtablissement de santé
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The Royal Melbourne Hospital Department of Intensive Care pays non établi dans la noticeOrganisme public
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Monash University pays non établi dans la noticeUniversité ou école supérieure
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Monash Health pays non établi dans la noticeÉtablissement de santé
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Alfred Health pays non établi dans la noticeÉtablissement de santé
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Department of Infectious Diseases and Immunology pays non établi dans la noticeInstitution
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National Centre for Infections in Cancer pays non établi dans la noticeInstitution
Peter MacCallum Cancer Centre, Peter Doherty Institute et Data Analytics Research and Evaluation Centre — Austin Health, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.