国际抗生素过敏国家网络（iNAAN）：一项2型混合有效性-实施多中心前瞻性队列研究及目标试验模拟研究的方案，该研究通过直接口服激发试验评估青霉素过敏标签去除情况。
International Network of Antibiotic Allergy Nations (iNAAN): Protocol for a type 2 hybrid effectiveness-implementation multicentre prospective cohort and target trial emulation study evaluating penicillin allergy delabeling via direct oral challenge.
作者信息
Mitri Elise A, Fletcher Luke R, Paynter Camille, Vogrin Sara, James Fiona, Ng Irvin, Holmes Natasha E, Ierano Courtney, Roberts Jason A, Fernando Suran L, Klaic Marlena, Trubiano Jason A
机构信息
Department of Infectious Diseases, at the Peter Doherty Institute for Infection and Immunology, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.
Centre for Antibiotic Allergy and Research, Department of Infectious Diseases and Immunology, Austin Health, Melbourne, Victoria, Australia.
出版信息
PLoS One. 2025 Sep 5;20(9):e0330724. doi: 10.1371/journal.pone.0330724. eCollection 2025.
BACKGROUND
Penicillin allergies are reported in 1 in 10 hospitalised patients globally and are associated with inferior patient and health service outcomes. However, more than 95% of low-risk penicillin allergies can be removed by direct oral challenge (DOC).
OBJECTIVE
The International Network of Antibiotic Allergy Nations (iNAAN) aims to evaluate the utility of an audit and feedback (A&F) and education implementation strategy to increase the adoption of penicillin DOC in patients with a low-risk penicillin allergy, while concurrently assessing the impact of penicillin DOC on antibiotic prescribing and health service outcomes.
METHODS
This is an international, multicentre type 2 hybrid effectiveness-implementation trial evaluating the widespread safety, clinical effectiveness and implementation of penicillin allergy delabeling via DOC, following penicillin allergy assessment using a purpose-built digital penicillin allergy toolkit within a smartphone application. The implementation strategy encompasses evaluation of co-designed digitally delivered bimonthly A&F reports to health services and clinicians, beginning a minimum of three months post site-activation, and optional education sessions that are delivered by the study team. The primary effectiveness outcome is the proportion of patients with a low-risk penicillin allergy that are delabeled following DOC. The primary implementation outcome is clinician adoption of the digital penicillin allergy toolkit within 6-months of site activation. Participants include adult patients who report a penicillin allergy and have undertaken a formalised penicillin allergy assessment, with or without DOC, at a participating health service. A target trial emulation approach will be used to analyse secondary effectiveness outcomes, including the impact of penicillin DOC on international antibiotic prescribing, infection-related and health service outcomes.
DISCUSSION
This study protocol presents a type 2 hybrid effectiveness-implementation trial design that will provide high level evidence to aid widespread implementation of penicillin DOC.
TRIAL REGISTRATION
ACTRN12623000484640 (https://www.anzctr.org.au/) (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385815&isReview=true).
背景
全球每10名住院患者中就有1人报告对青霉素过敏，且这与较差的患者及医疗服务结果相关。然而，超过95%的低风险青霉素过敏可通过直接口服激发试验（DOC）消除。
目的
国际抗生素过敏国家网络（iNAAN）旨在评估审核与反馈（A&F）及教育实施策略的效用，以提高低风险青霉素过敏患者对青霉素DOC的采用率，同时评估青霉素DOC对抗生素处方及医疗服务结果的影响。
方法
这是一项国际多中心2型混合有效性-实施试验，通过智能手机应用程序中的专用数字青霉素过敏工具包进行青霉素过敏评估后，评估通过DOC进行青霉素过敏去标签的广泛安全性、临床有效性及实施情况。实施策略包括评估为医疗服务机构和临床医生共同设计的每两个月一次的数字化A&F报告，该报告在站点激活后至少三个月开始提供，以及由研究团队提供的可选教育课程。主要有效性结局是低风险青霉素过敏患者在DOC后被去标签的比例。主要实施结局是临床医生在站点激活后6个月内采用数字青霉素过敏工具包。参与者包括在参与的医疗服务机构报告青霉素过敏并已进行正式青霉素过敏评估（无论是否进行DOC）的成年患者。将采用目标试验模拟方法分析次要有效性结局，包括青霉素DOC对国际抗生素处方、感染相关及医疗服务结果的影响。
讨论
本研究方案提出了一种2型混合有效性-实施试验设计，将提供高水平证据以帮助广泛实施青霉素DOC。
试验注册
ACTRN12623000484640（https://www.anzctr.org.au/）（https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385815&isReview=true）。
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